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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
Xiamen Compower Medical Tech. Co., Ltd.
Unit 301, No.16, Xianghong Road,
Xiang'An Torch Industrial Zone
Xiamen,  CN 361101
Applicant Contact Lifen Chen
Zi-medical, Inc.
93 Springs Rd
Bedford,  MA  01730
Correspondent Contact Mingzi Hussey
Regulation Number868.5915
Classification Product Code
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