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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 K211824
Device Name HERA W9, HERA W10 Diagnostic Ultrasound System
Applicant
Samsung Medison Co., Ltd.
3366, Hanseo-ro, Nam-myeon
Hongcheon-gun,  KR 25108
Applicant Contact Scully Kim
Correspondent
Samsung Medison Co., Ltd.
3366, Hanseo-ro, Nam-myeon
Hongcheon-gun,  KR 25108
Correspondent Contact Scully Kim
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received06/14/2021
Decision Date 09/09/2021
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
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