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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 K192903
Device Name RS85 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 Received10/15/2019
Decision Date 01/06/2020
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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