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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K181998
Device Name CardioBand ECG Event Recorder
Applicant
Samsung Strategy and Innovation Center (Ssic)
3655 N. First St.
San Jose,  CA  95134
Applicant Contact Bhupinder Singh
Correspondent
Samsung Strategy and Innovation Center (Ssic)
3655 N. First St.
San Jose,  CA  95134
Correspondent Contact Matthew Wiggins
Regulation Number870.2340
Classification Product Code
DPS  
Date Received07/26/2018
Decision Date 11/15/2018
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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