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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 K153581
Device Name Bladder Scanner
Applicant
Caresono Technology Co., Ltd.
4th Floor, No.11 Building Initiating Zone
Instruments And Meters Industry Base,Near Port Industry Zone
Dangdong,  TW 118009
Applicant Contact Yuzhong Ma
Correspondent
SHENZHEN HLONGMED BIOTECH COMPANY
R15-08, EAST BUILDING, YIHAI PLAZA, CHUANGYE ROAD,
NANSHAN DISTRICT
SHENZHEN,  CN 518054
Correspondent Contact Long Yang
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received12/15/2015
Decision Date 04/08/2016
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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