510(k) Device definition

510(k) Device means a new device that the FDA agrees is substantially equivalent to a device already on the market. 510(K) devices can be marketed without clinical testing. However, if clinical data are necessary to demonstrate substantial equivalence, any clinical studies must be conducted in compliance with the requirements of the IDE, IRB review and informed consent regulations.
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Examples of 510(k) Device in a sentence

  • Once the manufacturer has ensured the satisfactory completion of this process, a "Special 510(k): Device Modification" may be submitted.

  • She assumed these roles because Mr. Sundin was suffering from bacterial overgrowth syndrome and because he 6 In addition, the FTC submitted fifty-three (53) sworn cus- tomer declarations detailing consumer interactions with forty- seven (47) of Defendants’ products.

  • Special 510(k) Device modification ODE review memorandum- Veridex, LLC (K103502).

  • APPENDIX A Special 510(k): Device Modification A Special 510(k) is for manufacturers who intend to modify their own currently 510(k) cleared legally marketed liquid chemical sterilant/high level disinfectant.

  • All staff that drives the Centre’s vehicle will be required to have a valid Class 4 Driver’s license and will adhere to all rules and regulations of the HighwayTraffic Act at all times.

  • In addition to the traditional 510(k), this document describes two alternatives, the “Special 510(k): Device Modification” and the “Abbreviated 510(k)”.

  • The material submitted in this Special 510(k): Device Modifications of the LIAISON® Anti-HAV run on the LIAISON XS Analyzer (k1293532) is complete and supports a substantial equivalence decision.

  • Purpose of the Special 510(k) Submission Stryker submits this Special 510(k): Device Modification to request clearance for a modification to our Stryker Bone and Vertebral Body Biopsy Kit(s).

  • Appoint a representative to the DDC and provide administrative and management support to the DDC.

  • The Special 510(k): Device Modification utilizes certain aspects of the Quality System Regulation and the Abbreviated 510(k) relies on the use of guidance documents, special controls, and recognized standards to facilitate 510(k) review.

Related to 510(k) Device

  • Mobile Device means a computing device, typically smaller than a notebook, which runs a mobile operating system, such as iOS, Android, or Windows Phone. Mobile Devices include smart phones, most tablets, and other form factors.

  • Cephalometric device means a device intended for the radiographic visualization and measurement of the dimensions of the human head.

  • Orthotic device means a custom-fitted or custom-fabricated medical device that is applied to a part of the human body to correct a deformity, improve function, or relieve symptoms of a disease.

  • Network Interface Device or "NID" is a Network Element (including all of its features, functions and capabilities) that includes any means of Interconnection of End User Customer premises wiring to Qwest's distribution plant, such as a cross connect device used for that purpose. "New Service Provider" means the Party to which an End User Customer switches its local Exchange Service or the Party to which an End User Customer is porting its telephone number(s).

  • Spot-film device means a device intended to transport or position a radiographic image receptor between the x-ray source and fluoroscopic image receptor. It includes a device intended to hold a cassette over the input end of an image intensifier for the purpose of making a radiograph.

  • Control device means equipment (such as an incinerator or carbon adsorber) used to reduce, by destruction or removal, the amount of air contaminants in an air stream prior to discharge to the ambient air.

  • Tracking device means equipment that records the location, whether directly or indirectly, of Employees, whether by the use of equipment that uses Global Positioning System (GPS) or by another like means.

  • Defeat device means any element of design which senses temperature, vehicle speed, engine rotational speed, drive gear, manifold vacuum or any other parameter for the purpose of activating, modulating, delaying or deactivating the operation of any part of the emission control system that reduces the effectiveness of the emission control system under conditions which may reasonably be expected to be encountered in normal vehicle operation and use. Such an element of design shall not be considered a defeat device if:

  • Access Device means a card, plate, code, account number, per- sonal identification number, electronic serial number, mobile identi- fication number, or other telecommunications service, equipment, or instrument identifier or means of account access that alone or in conjunction with another device may be used to:

  • Security Device means any passwords, User identification numbers, certificates, or other form(s) of authentication or security used to access the Service.

  • Prescription device means an instrument, apparatus, implement, machine,

  • Device means instruments, apparatus, and contrivances, including their components, parts, and

  • in vitro diagnostic medical device means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:

  • Ignition interlock device means a device that, without tampering or intervention by another person, would prevent the defendant from operating a motor vehicle if the defendant has a blood or breath alcohol concentration of five-hundredths (0.05) or greater; and

  • Sensor means any measurement device that is not part of the vehicle itself but installed to determine parameters other than the concentration of gaseous and particle pollutants and the exhaust mass flow.

  • Assistive device means any item, piece of equipment, or product system which is used to increase, maintain, or improve the functional capabilities of an individual with a disability in the workplace or on the job. “Assistive device” does not mean any medical device, surgical device, or organ implanted or transplanted into or attached directly to an individual. “Assistive device” does not include any device for which a certificate of title is issued by the state department of transportation, but does include any item, piece of equipment, or product system otherwise meeting the definition of “assistive device” that is incorporated, attached, or included as a modification in or to such a device issued a certificate of title.

  • Capture device means a hood, enclosed room, floor sweep, or other means of collecting solvent emissions or other pollutants into a duct. The pollutant can be directed to a pollution control device such as an incinerator or carbon adsorber.

  • Electronic device technology means any technology that involves microelectronics, semiconductors, electronic equipment, and instrumentation, radio frequency, microwave, and millimeter electronics; optical and optic-electrical devices; or data and digital communications and imaging devices.

  • Prosthetic device means a replacement, corrective, or supportive device, other than contact lenses and dental prosthesis, dispensed pursuant to a prescription, including repair or replacement parts for that device, worn on or in the body to do 1 or more of the following:

  • Traffic control device means a flagger, sign, signal, marking, or other device used to regulate, warn or guide traffic, placed on, over, or adjacent to a street, highway, private road open to public travel, pedestrian facility, or shared-use path by authority of a public agency or official having jurisdiction, or, in the case of a private road open to public travel, by authority of the private owner or private official having jurisdiction.

  • Assistive technology device means any item, piece of equipment, or product system that is used to increase, maintain, or improve the functional capacities of a child with a disability.

  • Encapsulation means the application of an encapsulant.

  • Approved Device means a device described in Subsection 20A-21-201(4) used to

  • medical device means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

  • Portable Device means any computing device with a small form factor, designed to be transported from place to place. Portable devices are primarily battery powered devices with base computing resources in the form of a processor, memory, storage, and network access. Examples include, but are not limited to, mobile phones, tablets, and laptops. Mobile Device is a subset of Portable Device.

  • Assistive Devices means any category of durable medical equipment, mechanical apparatus, electrical appliance, or instrument of technology used to assist and enhance an individual's independence in performing any activity of daily living. Assistive devices include the use of service animals, general household items, or furniture to assist the individual.