FDA 510(k)

Masque chirurgical à usage unique modèle FE2311B

Numéro K : K210970 · 2021-07-21

DemandeurByd Precison Manufacturer Co., Ltd.

Date de décision2021-07-21

Code produitFXX

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

Single-Use Surgical Mask Model FE2311B is the device name listed in this FDA 510(k) record. The listed applicant is Byd Precison Manufacturer Co., Ltd.. It received FDA 510(k) clearance on 2021-07-21 under 510(k) number K210970. 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 Single-Use Surgical Mask Model FE2311B?

Single-Use Surgical Mask Model FE2311B is a medical device that received FDA 510(k) clearance on 2021-07-21. The listed applicant is Byd Precison Manufacturer Co., Ltd.. The 510(k) number is K210970.

When did Single-Use Surgical Mask Model FE2311B receive FDA 510(k) clearance?

Single-Use Surgical Mask Model FE2311B received FDA 510(k) clearance on 2021-07-21, under 510(k) number K210970.

Who is the listed applicant for Single-Use Surgical Mask Model FE2311B?

The FDA 510(k) record lists Byd Precison Manufacturer Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single-Use Surgical Mask Model FE2311B?

The FDA product code for Single-Use Surgical Mask Model FE2311B is FXX.

Essais cliniques associés

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Dispositifs connexes (Code : FXX)

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Source officielle

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