FDA 510(k)

ClearMask Transparent Surgical Face Mask

Numéro K : K200576 · 2020-04-06

Date de décision2020-04-06

Code produitFXX

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

ClearMask Transparent Surgical Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Clearmask, LLC. It received FDA 510(k) clearance on 2020-04-06 under 510(k) number K200576. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the ClearMask Transparent Surgical Face Mask?

ClearMask Transparent Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2020-04-06. The listed applicant is Clearmask, LLC. The 510(k) number is K200576.

When did ClearMask Transparent Surgical Face Mask receive FDA 510(k) clearance?

ClearMask Transparent Surgical Face Mask received FDA 510(k) clearance on 2020-04-06, under 510(k) number K200576.

Who is the listed applicant for ClearMask Transparent Surgical Face Mask?

The FDA 510(k) record lists Clearmask, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ClearMask Transparent Surgical Face Mask?

The FDA product code for ClearMask Transparent Surgical Face Mask is FXX.

Essais cliniques associés

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Dispositifs connexes (Code : FXX)

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Source officielle

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