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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Magnetic Tape, Medical
510(k) Number K231289
Device Name S-Patch Ex Wearable ECG Patch
Applicant
Wellysis Corp.
8F, 425 Teheran-ro, Gangnam-gu
Seoul,  KR 06159
Applicant Contact DoGyun Im
Correspondent
MCRA, LLC
803 7th Street NW
Washington,  DC  20001
Correspondent Contact Nikki Batista
Regulation Number870.2800
Classification Product Code
DSH  
Date Received05/04/2023
Decision Date 08/30/2023
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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