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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 K110207
Model PROSOUND F75
Device Name ALOKA PROUSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM
Original Applicant
ALOKA CO., LTD.
10 fairfield blvd.
wallingford,  CT  06492 7502
Original Contact richard cehovsky
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received01/25/2011
Decision Date 02/17/2011
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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