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FDA 510(k)

CPR Face Shield

K-Number: K192285 · 2020-11-25

ApplicantFirstar Healthcare Company Limited (Guangzhou)
Decision Date2020-11-25
Product CodeCBP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Devices (Code: CBP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241366QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)Dehas Medical Systems GmbHK234053F&P Optiflow Flow DiverterFisher & Paykel Healthcare, Ltd.K210992Altech® Exhalation Valve (Single Limb and Dual Limb)Meditera Tibbi Malzeme San VE Tic ASK173770OJR215 Pressure Relief ManifoldFisher & Paykel Healthcare LimitedK171961Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm)Xiamen Compower Medical Tech. Co., Ltd.K152521Seal Rite Non-Rebreathing ValveThe Lifeguard Store, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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