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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 K210591
Device Name Palm Bladder Scanner - PBSV7.1
Applicant
Mianyang Meike Electronic Equipment Co., Ltd.
No., 63, Yinping Road, Longmen Town, Fucheng District,
Mianyang. Sichuan
Mianyang,  CN 621000
Applicant Contact Wenjun Zhao
Correspondent
Wenzhou Cytech Information Service Co., Ltd.
Room302, Building 3, Hangqian Mansion, Hangqian Street
Lucheng District
Wenzhou,  CN 325000
Correspondent Contact Helen Nan
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received03/01/2021
Decision Date 06/09/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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