Keyword Analysis & Research: fda 510k types

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What does FDA device listing number mean?

Definition 1 A number assigned by the FDA to a device during Registration and Listing.

What is a 510k number?

A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR §807.92(a)(3)) that is not subject to premarket approval. Learn more...

What is 510K clearance?

510(k) Clearance. The purpose of a 510(k) submission is to demonstrate that a device is “substantially equivalent” to a predicate device (one that has been cleared by the FDA or marketed before 1976).

What is the classification of FDA?

The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels.

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