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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 K121867
Model 60/50/40/30/20/10
Device Name SONOTOUCH SERIES DIAGNOSTIC ULTRASOUND SYSTEMS
Original Applicant
CHISON MEDICAL IMAGING CO., LTD.
no. 8, xiang nan road
shuo fang, new district
wuxi,  CH 214142
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received06/26/2012
Decision Date 08/02/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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