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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 K162583
Device Name ALOKA LISENDO 880
Applicant
HITACHI, LTD.
10 FAIRFIELD BLVD
WALLINGFORD,  CT  06492 -5903
Applicant Contact ANGELA VAN ARSDALE
Correspondent
HITACHI, 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 Received09/15/2016
Decision Date 11/17/2016
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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