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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Physiological Signal, Radiofrequency
510(k) Number K132148
FOIA Releasable 510(k) K132148
Device Name S HEALTH
Applicant
Samsung Electronics Co., Ltd.
129, Samsung-Ro,
Yeongtong-Gu
Suwon-Si, Gyeonggi-Do,  KR 443-742
Applicant Contact Priscilla Chung
Correspondent
Samsung Electronics Co., Ltd.
129, Samsung-Ro,
Yeongtong-Gu
Suwon-Si, Gyeonggi-Do,  KR 443-742
Correspondent Contact Priscilla Chung
Regulation Number870.2910
Classification Product Code
DRG  
Subsequent Product Codes
DXN   FRI   NBW  
Date Received07/11/2013
Decision Date 12/04/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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