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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 K113304
Device Name BLADDER SCANNER
Applicant
MEDA Co., Ltd.
13505 Broadfield Dr.
Potomac,  MD  20854
Applicant Contact KAI CHEN
Correspondent
MEDA Co., Ltd.
13505 Broadfield Dr.
Potomac,  MD  20854
Correspondent Contact KAI CHEN
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received11/08/2011
Decision Date 03/23/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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