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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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