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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 K263254
Device Name Disposable Manual Resuscitator (NPVC-001/RTMA;NPVC-002/RTMA;NPVC-003/RTMA1)
Applicant
Xiamen Compower Medical Tech. Co., Ltd.
Unit 301, #16, Xianghong Rd., Xiang’An Torch Industrial Zone
Xiamen,  CN 361101
Applicant Contact Jenny Chen
Correspondent
Shanghai Sungo Management Consulting Co., Ltd.
Rm. 1401, Dongfang Bldg., 1500# Century Ave., Shanghai 20012
Shanghai,  CN 200122
Correspondent Contact Eva Li
Regulation Number868.5915
Classification Product Code
BTM  
Date Received09/17/2026
Decision Date 10/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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