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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 K134016
Device Name ARIETTA 70/ARIETTA S70/ARIETTA V70 DIAGNOSTIC ULTRASOUND SCANNER
Applicant
Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical
10 Fairfield Blvd.
Wallingford,  CT  06492 -7502
Applicant Contact ANGELA VANARSDALE
Correspondent
Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical
10 Fairfield Blvd.
Wallingford,  CT  06492 -7502
Correspondent Contact ANGELA VANARSDALE
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received12/30/2013
Decision Date 03/28/2014
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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