FDA 510(k)

Medical Surgical Mask (Model: JM92, JM92B)

Numéro K : K220187 · 2022-03-25

DemandeurGuangdong Jia Mei Biological Technology Co.Ltd

Date de décision2022-03-25

Code produitFXX

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

Medical Surgical Mask (Model: JM92, JM92B) is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Jia Mei Biological Technology Co.Ltd. It received FDA 510(k) clearance on 2022-03-25 under 510(k) number K220187. 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 Surgical Mask (Model: JM92, JM92B)?

Medical Surgical Mask (Model: JM92, JM92B) is a medical device that received FDA 510(k) clearance on 2022-03-25. The listed applicant is Guangdong Jia Mei Biological Technology Co.Ltd. The 510(k) number is K220187.

When did Medical Surgical Mask (Model: JM92, JM92B) receive FDA 510(k) clearance?

Medical Surgical Mask (Model: JM92, JM92B) received FDA 510(k) clearance on 2022-03-25, under 510(k) number K220187.

Who is the listed applicant for Medical Surgical Mask (Model: JM92, JM92B)?

The FDA 510(k) record lists Guangdong Jia Mei Biological Technology Co.Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical Surgical Mask (Model: JM92, JM92B)?

The FDA product code for Medical Surgical Mask (Model: JM92, JM92B) is FXX.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

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Dispositifs connexes (Code : FXX)

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Source officielle

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