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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 K142368
Device Name NOBLUS DIAGNOSTIC ULTRASOUND SCANNER
Applicant
HITACHI ALOKA MEDICAL, LTD.
10 FAIRFIELD BLVD.
WALLINGFORD CT,  CT  06492 -7502
Applicant Contact ANGELA VAN ARSDALE
Correspondent
HITACHI ALOKA MEDICAL, LTD.
10 FAIRFIELD BLVD.
WALLINGFORD CT,  CT  06492 -7502
Correspondent Contact ANGELA VAN ARSDALE
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received08/25/2014
Decision Date 01/14/2015
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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