predicate device definition

predicate device means a device, first time and first of its kind, approved for manufacture for sale or for import by the Central Licensing Authority and has the similar intended use, material of construction, and design characteristics as the device which is proposed for licence in India;

Related to predicate device

  • 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:

  • 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:

  • 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.

  • compatibility means compatibility as defined in point (10) of Article 2 of Directive (EU) 2019/770;

  • 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:

  • 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.

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

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

  • Encapsulation means the application of an encapsulant.

  • 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.

  • Companion Diagnostic means a device which is essential for the safe and effective use of a corresponding medicinal product to:

  • Payment device means any credit card as defined in 15 U.S.C. § 1602(k) or any "accepted card or

  • Feedback means input regarding the SAP Products, services, business or technology plans, including, without limitation, comments or suggestions regarding the possible creation, modification, correction, improvement or enhancement of the SAP Products and/or services, or input as to whether Partner believes SAP’s development direction is consistent with their own business and IT needs.

  • Collimator means a radiation shield that is placed on the end of the guide tube or directly onto a radiographic exposure device to restrict the size of the radiation beam when the sealed source is cranked into position to make a radiographic exposure.

  • 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.

  • Fabrication means making up data or results and recording or reporting them.

  • Investigational Medicinal Product means the study drug or control material as defined in the Protocol.

  • FedRAMP means the Federal Risk and Authorization Management Program (see xxx.xxxxxxx.xxx), which is an assessment and authorization process that federal government agencies have been directed to use to ensure security is in place when accessing Cloud computing products and services.

  • 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.

  • Stack means any point in a source designed to emit solids, liquids, or gases into the air, including a pipe or duct but not including flares.

  • 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.

  • 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.

  • Gambling device means a mechanical, electromechanical, or electronic device, machine, slot

  • Protective device means an individually fabricated mechanical device or physical barrier, the use of which is incorporated in the individualized written plan of service. The use of a protective device is intended to prevent the minor child from causing serious self-injury associated with documented, frequent, and unavoidable hazardous events.

  • Vector means a carrier that is capable of transmitting a pathogen from one organism to another including, but not limited to, flies and other insects, rodents, birds, and vermin.

  • Investigational Product means the Study Drug identified above and the control material, as further detailed in the Protocol;