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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 K123828
Device Name PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM
Applicant
HITACHI ALOKA MEDICAL, LTD.
10 FAIRFIELD BLVD.
WALLINGFORD,  CT  06492 -5903
Applicant Contact ANGELA VAN ARSDALE
Correspondent
HITACHI ALOKA MEDICAL, LTD.
10 FAIRFIELD BLVD.
WALLINGFORD,  CT  06492 -5903
Correspondent Contact ANGELA VAN ARSDALE
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received12/12/2012
Decision Date 01/18/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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