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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 K191233
Device Name ARIETTA 750
Applicant
Hitachi Healthcare Americas
1959 Summit Commerce Park
twinsburg,  OH  44087
Applicant Contact aaron pierce
Correspondent
Hitachi Healthcare Americas
1959 Summit Commerce Park
twinsburg,  OH  44087
Correspondent Contact aaron pierce
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received05/08/2019
Decision Date 08/09/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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