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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Emergency, Manual (Resuscitator)
510(k) Number K210288
Device Name Disposable Manual Resuscitator
Applicant
Xiamen Compower Medical Tech. Co., Ltd.
Unit 301, #16, Xianghong Rd.,
Xiang'An Torch Industrial Zone
Xiamen,  CN 361101
Applicant Contact Lifen Chen
Correspondent
Zi-medical, Inc.
93 Springs Rd.,
Bedford,  MA  01730
Correspondent Contact Mingzi Hussey
Regulation Number868.5915
Classification Product Code
BTM  
Date Received02/02/2021
Decision Date 08/26/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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