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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 K121329
Model SSIP90029
Device Name AIXPLORER
Original Applicant
SUPERSONIC IMAGINE
510 rue rene descartes
aix-en-provence,  FR 13857
Original Contact jacques souquet
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received05/02/2012
Decision Date 08/24/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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