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)— 510(k) K171961

Name: FDA 510(k) clearance K171961
Creator: U.S. Food and Drug Administration
Published: 2017-11-17

Substantially Equivalent

Xiamen Compower Medical Tech. Co., Ltd.

FDA 510(k) clearance K171961 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), Substantially Equivalent on 2017-11-17. Applicant: Xiamen Compower Medical Tech. Co., Ltd.. Device class: 2.

Clearance details

Applicant: Xiamen Compower Medical Tech. Co., Ltd.
Product code: Code CBP
Device class: Class 2
Regulation: 21 CFR 868.5870
Advisory panel: Anesthesiology
Date received: 2017-06-30
Decision date: 2017-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Xiamen, CN

Download summary PDF View on FDA.gov ↗

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