Examples of 510(k) Clearance in a sentence
Institute of Medicine, Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years, Washington, DC, July 2011, p.
These reports are listed in Institute of Medicine (IOM), Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years, Washington, DC, July 2011, p.
Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years.
Public Health Effectiveness of the FDA 510(k) Clearance Process: Measuring Postmarket Performance and Other Select Topics: Workshop Report.
Among our products intended for the U.S. market, the VenusP-Valve and VenusA-Valve are likely to be classified as Class III devices in the U.S. An Overview of the Premarket Notification and Premarket Approval Processes Premarket Notification (510(k) Clearance) The FDCA requires any person who wishes to market a medical device for which a premarket approval application is not required to submit a premarket notification (a 510(k)) unless exempt (e.g., Class I, 510(k)-exempt medical devices).