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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 K230084
Device Name HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System
Applicant
Samsung Medison CO., LTD.
3366, Hanseo-ro, Nam-myeon
Hongcheon-gun,  KR 25108
Applicant Contact So-yeon Jang
Correspondent
Samsung Medison CO., LTD.
3366, Hanseo-ro, Nam-myeon
Hongcheon-gun,  KR 25108
Correspondent Contact So-yeon Jang
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received01/11/2023
Decision Date 04/21/2023
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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