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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 K173513
Device Name WS80A Diagnostic Ultrasound System
Applicant
Samsung Medison Co., Ltd.
42, Teheran-ro 108-gil
Seoul,  KR 06176
Applicant Contact Ji Yea Lee
Correspondent
Samsung Medison Co., Ltd.
42, Teheran-ro 108-gil
Seoul,  KR 06176
Correspondent Contact Ji Yea Lee
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received11/13/2017
Decision Date 02/20/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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