Disposable Manual Resuscitator

Ventilator, Emergency, Manual (resuscitator)

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 Disposable Manual Resuscitator.

Pre-market Notification Details

Device IDK210288
510k NumberK210288
Device Name:Disposable Manual Resuscitator
ClassificationVentilator, Emergency, Manual (resuscitator)
Applicant Xiamen Compower Medical Tech. Co., Ltd. Unit 301, No.16, Xianghong Road, Xiang'An Torch Industrial Zone Xiamen,  CN 361101
ContactLifen Chen
CorrespondentMingzi Hussey
Zi-medical, Inc. 93 Springs Rd Bedford,  MA  01730
Product CodeBTM  
CFR Regulation Number868.5915 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-02
Decision Date2021-08-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06946430410887 K210288 000
16946430410877 K210288 000
16946430410860 K210288 000
16946430410853 K210288 000
16946430410846 K210288 000
16946430410839 K210288 000

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