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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 K121577
Model SSH-880CV
Device Name APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM
Applicant
TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN
2441 michelle dr
tustin,  CA  92780
Contact charlemagne chua
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received05/30/2012
Decision Date 06/22/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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