Keyword Analysis & Research: fda releasable 510 k database


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Frequently Asked Questions

How do I search the releasable 510 (k) database?

You can search the releasable 510 (k) database by Panel, 510 (k) number, Product code or Device name. A search query will produce information from the database in the following format:

What is a 510k FDA?

510 (k) Premarket Notification. A 510 (K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513 (i) (1) (A) FD&C Act) that is not subject to premarket approval.

What is a 510k premarket submission?

510(k) Premarket Notification. 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.

What is PMN (premarket notification) or 510 (k)?

Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k).


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