FDA 510(k)

WYZ Surgical Mask

Numéro K : K211576 · 2021-08-19

Date de décision2021-08-19

Code produitFXX

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

WYZ Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Wyz Medical Supplies, LLC. It received FDA 510(k) clearance on 2021-08-19 under 510(k) number K211576. 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 WYZ Surgical Mask?

WYZ Surgical Mask is a medical device that received FDA 510(k) clearance on 2021-08-19. The listed applicant is Wyz Medical Supplies, LLC. The 510(k) number is K211576.

When did WYZ Surgical Mask receive FDA 510(k) clearance?

WYZ Surgical Mask received FDA 510(k) clearance on 2021-08-19, under 510(k) number K211576.

Who is the listed applicant for WYZ Surgical Mask?

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

What is the FDA product code for WYZ Surgical Mask?

The FDA product code for WYZ Surgical Mask is FXX.

Essais cliniques associés

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Dispositifs connexes (Code : FXX)

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Source officielle

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