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FDA 510(k)

CPR MASK

K-Number: K083418 · 2010-07-22

ApplicantFirstar Healthcare Co., Ltd.
Decision Date2010-07-22
Product CodeCBP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CPR MASK is the device name listed in this FDA 510(k) record. The listed applicant is Firstar Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2010-07-22 under 510(k) number K083418. 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 MASK?

CPR MASK is a medical device that received FDA 510(k) clearance on 2010-07-22. The listed applicant is Firstar Healthcare Co., Ltd.. The 510(k) number is K083418.

When did CPR MASK receive FDA 510(k) clearance?

CPR MASK received FDA 510(k) clearance on 2010-07-22, under 510(k) number K083418.

Who is the listed applicant for CPR MASK?

The FDA 510(k) record lists Firstar Healthcare Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CPR MASK?

The FDA product code for CPR MASK 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 ASK192285CPR Face ShieldFirstar Healthcare Company Limited (Guangzhou)K173770OJR215 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.

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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