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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 K072210
Device Name CHISON, MODEL 8300
Original Applicant
CHISON MEDICAL IMAGING CO., LTD.
ste 8 zhongshan mansion, lane
999, zhongshan no.02 rd (s)
shanghai,  CH 200030
Original Contact diana hong
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received08/09/2007
Decision Date 08/24/2007
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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