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)

Valve, Non-rebreathing

Xiamen Compower Medical Tech. Co. Ltd.

The following data is part of a premarket notification filed by Xiamen Compower Medical Tech. Co. Ltd. with the FDA 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).

Pre-market Notification Details

Device IDK171961
510k NumberK171961
Device Name: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)
ClassificationValve, Non-rebreathing
Applicant Xiamen Compower Medical Tech. Co. Ltd. Unit 301, No.16 Xianghong Road, Xiang'an Torch Industrial Zone Xiamen,  CN 361101
ContactLifen Chen
CorrespondentLynn Jensen
NAMSA 400 Highway 169 South Suite 500 Minneapolis,  MN  55426
Product CodeCBP  
CFR Regulation Number868.5870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-06-30
Decision Date2017-11-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
26946430400288 K171961 000
16946430410280 K171961 000
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20193489021414 K171961 000
16946430414370 K171961 000
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06946430400161 K171961 000
16946430400182 K171961 000
26946430400271 K171961 000
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16946430400250 K171961 000
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16946430400229 K171961 000
16946430400212 K171961 000
16946430400205 K171961 000
16946430400199 K171961 000
16946430415827 K171961 000

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