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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 K191115
Device Name RS85 Diagnostic Ultrasound System
Samsung Medison Co., Ltd
3366 Hanseo-ro,Nam-myeon
hongcheon-gun,  KR 25108
Applicant Contact ji yea lee
Samsung Medison Co., Ltd
3366, Hanseo-ro, Nam-myeon
hongcheon-gun, gangwon-do,  KR 25108
Correspondent Contact ji yea lee
Regulation Number892.1550
Classification Product Code
Subsequent Product Codes
Date Received04/26/2019
Decision Date 06/12/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No