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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 K223448
Device Name Bladder Scanner Model: BVT02
Applicant
Xuzhou Kaixin Electronic Instrument Co., Ltd.
Kaixin Mansion, C-01, Economic Development Zone
Xuzhou,  CN 221004
Applicant Contact Chunmei Xu
Correspondent
Shenzhen Hlongmed Biotech Co., Ltd.
1201, Haosheng Business Center, 4096 Dongbin Road, Nanshan
Shenzhen, P.R.C
Shenzhen,  CN 518054
Correspondent Contact Long Yang
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received11/15/2022
Decision Date 07/07/2023
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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