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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 K130308
Device Name NOBLUS ULTRASOUND DIAGNOSTIC SYSTEM
Applicant
HITACHI ALOKA MEDICAL, LTD.
10 FAIRFIELD BLVD.
WALLINGFORD,  CT  06492 -7502
Applicant Contact ANGELA VANARSDALE
Correspondent
HITACHI ALOKA MEDICAL, LTD.
10 FAIRFIELD BLVD.
WALLINGFORD,  CT  06492 -7502
Correspondent Contact ANGELA VANARSDALE
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received02/07/2013
Decision Date 04/05/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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