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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 Doppler, Ultrasonic
510(k) Number K131305
Device Name CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINCAR PROBE, PHASED PROBE
Applicant
Chison Medical Imaging Co., Ltd.
7263 Cronin Circle
Dublin,  CA  94568
Applicant Contact BOB LEIKER
Correspondent
Chison Medical Imaging Co., Ltd.
7263 Cronin Circle
Dublin,  CA  94568
Correspondent Contact BOB LEIKER
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received05/07/2013
Decision Date 08/01/2013
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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