FDA 510(k)

Surgical Mask-Model Number: Ear Loop, Flat-Pleated

Numéro K : K201852 · 2021-03-02

DemandeurHuizhou Foryou Medical Devices Co., Ltd.

Date de décision2021-03-02

Code produitFXX

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

Surgical Mask-Model Number: Ear Loop, Flat-Pleated is the device name listed in this FDA 510(k) record. The listed applicant is Huizhou Foryou Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2021-03-02 under 510(k) number K201852. 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 Surgical Mask-Model Number: Ear Loop, Flat-Pleated?

Surgical Mask-Model Number: Ear Loop, Flat-Pleated is a medical device that received FDA 510(k) clearance on 2021-03-02. The listed applicant is Huizhou Foryou Medical Devices Co., Ltd.. The 510(k) number is K201852.

When did Surgical Mask-Model Number: Ear Loop, Flat-Pleated receive FDA 510(k) clearance?

Surgical Mask-Model Number: Ear Loop, Flat-Pleated received FDA 510(k) clearance on 2021-03-02, under 510(k) number K201852.

Who is the listed applicant for Surgical Mask-Model Number: Ear Loop, Flat-Pleated?

The FDA 510(k) record lists Huizhou Foryou Medical Devices Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Surgical Mask-Model Number: Ear Loop, Flat-Pleated?

The FDA product code for Surgical Mask-Model Number: Ear Loop, Flat-Pleated is FXX.

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Dispositifs connexes (Code : FXX)

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Source officielle

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