FDA 510(k)

Smith & Nephew Tablet Application

Numéro K : K190367 · 2019-05-21

Date de décision2019-05-21

Code produitQGY

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

Smith & Nephew Tablet Application is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew. It received FDA 510(k) clearance on 2019-05-21 under 510(k) number K190367. The device is classified under product code QGY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Smith & Nephew Tablet Application?

Smith & Nephew Tablet Application is a medical device that received FDA 510(k) clearance on 2019-05-21. The listed applicant is Smith & Nephew. The 510(k) number is K190367.

When did Smith & Nephew Tablet Application receive FDA 510(k) clearance?

Smith & Nephew Tablet Application received FDA 510(k) clearance on 2019-05-21, under 510(k) number K190367.

Who is the listed applicant for Smith & Nephew Tablet Application?

The FDA 510(k) record lists Smith & Nephew as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Smith & Nephew Tablet Application?

The FDA product code for Smith & Nephew Tablet Application is QGY.

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Source officielle

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