FDA 510(k)

Medical Face Masks, Model Name:MY020003

Numéro K : K211165 · 2021-11-09

DemandeurHuizhou Jie Bai Purification Co., Ltd.

Date de décision2021-11-09

Code produitFXX

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

Medical Face Masks, Model Name:MY020003 is the device name listed in this FDA 510(k) record. The listed applicant is Huizhou Jie Bai Purification Co., Ltd.. It received FDA 510(k) clearance on 2021-11-09 under 510(k) number K211165. 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 Medical Face Masks, Model Name:MY020003?

Medical Face Masks, Model Name:MY020003 is a medical device that received FDA 510(k) clearance on 2021-11-09. The listed applicant is Huizhou Jie Bai Purification Co., Ltd.. The 510(k) number is K211165.

When did Medical Face Masks, Model Name:MY020003 receive FDA 510(k) clearance?

Medical Face Masks, Model Name:MY020003 received FDA 510(k) clearance on 2021-11-09, under 510(k) number K211165.

Who is the listed applicant for Medical Face Masks, Model Name:MY020003?

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

What is the FDA product code for Medical Face Masks, Model Name:MY020003?

The FDA product code for Medical Face Masks, Model Name:MY020003 is FXX.

Essais cliniques associés

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Dispositifs connexes (Code : FXX)

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Source officielle

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