FDA 510(k)

Welspun Health Surgical Mask

Numéro K : K211536 · 2021-09-01

Date de décision2021-09-01

Code produitFXX

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

Welspun Health Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Welspun India Limited. It received FDA 510(k) clearance on 2021-09-01 under 510(k) number K211536. 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 Welspun Health Surgical Mask?

Welspun Health Surgical Mask is a medical device that received FDA 510(k) clearance on 2021-09-01. The listed applicant is Welspun India Limited. The 510(k) number is K211536.

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

Welspun Health Surgical Mask received FDA 510(k) clearance on 2021-09-01, under 510(k) number K211536.

Who is the listed applicant for Welspun Health Surgical Mask?

The FDA 510(k) record lists Welspun India Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Welspun Health Surgical Mask?

The FDA product code for Welspun Health 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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