Cleared Traditional

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)

K171961 · Xiamen Compower Medical Tech. Co., Ltd. · Anesthesiology

Nov 2017

Decision

140d

Days

Class 2

Risk

About This 510(k) Submission

K171961 is an FDA 510(k) clearance for 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), a Valve, Non-rebreathing (Class II — Special Controls, product code CBP), submitted by Xiamen Compower Medical Tech. Co., Ltd. (Xiamen, CN). The FDA issued a Cleared decision on November 17, 2017, 140 days after receiving the submission on June 30, 2017. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5870.

Submission Details

510(k) Number	K171961 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 30, 2017
Decision Date	November 17, 2017
Days to Decision	140 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF