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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, imaging, pulsed echo, ultrasonic
510(k) Number K213488
Device Name Bladder Scanner, Model Name:M5
Applicant
Suzhou Peaksonic Medical Technology Co., Ltd.
2A, West Side of Building G4, Kunshan Hi-Tech Medical Device
Industrial Park Qiandeng, Kunshan
Suzhou,  CN 215341
Applicant Contact Calvin Ma
Correspondent
Suzhou Peaksonic Medical Technology Co., Ltd.
2A, West Side of Building G4, Kunshan Hi-Tech Medical Device
Industrial Park Qiandeng, Kunshan
Suzhou,  CN 215341
Correspondent Contact Calvin Ma
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received11/01/2021
Decision Date 07/01/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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