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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph, Ambulatory (Without Analysis)
510(k) Number K253384
Device Name mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7)
Applicant
Seers Technology Co., Ltd.
(17707) 291-13, Dongbu-Daero
Jinwi-Myeon
Pyeongtaek-Si,  KR
Applicant Contact Stan Kim
Correspondent
Cardiovascular Biometrics Sourcing, LLC
6703 W. 131st St.
Overland Park,  KS  66209
Correspondent Contact Diane Horwitz
Regulation Number870.2800
Classification Product Code
MWJ  
Date Received09/30/2025
Decision Date 06/25/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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