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FDA 510(k)

Compower 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)

Número K: K171961 · 2017-11-17

RequerenteXiamen Compower Medical Tech. Co., Ltd.
Data da decisão2017-11-17
Código do produtoCBP
Comité consultivoAN
DecisãoSubstantially Equivalent

Resumo do dispositivo

Compower 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) is the device name listed in this FDA 510(k) record. The listed applicant is Xiamen Compower Medical Tech. Co., Ltd.. It received FDA 510(k) clearance on 2017-11-17 under 510(k) number K171961. The device is classified under product code CBP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Compower 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)?

Compower 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) is a medical device that received FDA 510(k) clearance on 2017-11-17. The listed applicant is Xiamen Compower Medical Tech. Co., Ltd.. The 510(k) number is K171961.

When did Compower 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) receive FDA 510(k) clearance?

Compower 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) received FDA 510(k) clearance on 2017-11-17, under 510(k) number K171961.

Who is the listed applicant for Compower 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)?

The FDA 510(k) record lists Xiamen Compower Medical Tech. Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Compower 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)?

The FDA product code for Compower 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) is CBP.

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Outros registros que listam Xiamen Compower Medical Tech. Co., Ltd. como candidato(a)

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Dispositivos Relacionados (Código: CBP)

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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 LimitedK152521Seal Rite Non-Rebreathing ValveThe Lifeguard Store, Inc.

Fonte oficial

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