FDA 510(k)

CPR Face Shield

Numéro K : K192285 · 2020-11-25

DemandeurFirstar Healthcare Company Limited (Guangzhou)

Date de décision2020-11-25

Code produitCBP

Comité consultatifAN

DécisionSubstantially Equivalent

Résumé du dispositif

CPR Face Shield is the device name listed in this FDA 510(k) record. The listed applicant is Firstar Healthcare Company Limited (Guangzhou). It received FDA 510(k) clearance on 2020-11-25 under 510(k) number K192285. The device is classified under product code CBP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the CPR Face Shield?

CPR Face Shield is a medical device that received FDA 510(k) clearance on 2020-11-25. The listed applicant is Firstar Healthcare Company Limited (Guangzhou). The 510(k) number is K192285.

When did CPR Face Shield receive FDA 510(k) clearance?

CPR Face Shield received FDA 510(k) clearance on 2020-11-25, under 510(k) number K192285.

Who is the listed applicant for CPR Face Shield?

The FDA 510(k) record lists Firstar Healthcare Company Limited (Guangzhou) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CPR Face Shield?

The FDA product code for CPR Face Shield is CBP.

Essais cliniques associés

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Dispositifs connexes (Code : CBP)

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Source officielle

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