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510(k) K171961

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) by Xiamen Compower Medical Tech. Co., Ltd. — Product Code CBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2017
Date Received
June 30, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Valve, Non-Rebreathing
Device Class
Class II
Regulation Number
868.5870
Review Panel
AN
Submission Type

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