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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 K182595
Device Name HERA W10 Diagnostic Ultrasound System
Applicant
Samsung Medison Co., Ltd.
3366, Hanseo-Ro, Nam-Myeon,
Hongcheon-Gun,  KR 25108
Applicant Contact Ji Yea Lee
Correspondent
Samsung Medison Co., Ltd.
3366, Hanseo-Ro, Nam-Myeon,
Hongcheon-Gun,  KR 25108
Correspondent Contact Ji Yea Lee
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received09/20/2018
Decision Date 12/18/2018
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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