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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 K111227
Model SSD-3500
Device Name ALOKA SSD-3500 DIAGNOSTIC ULTRASOUND SYSTEM
Original Applicant
ALOKA CO., LTD.
10 fairfield blvd.
wallingford,  CT  06492 7502
Original Contact yukitoshi kiyomura
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received05/02/2011
Decision Date 05/13/2011
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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