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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K203079
Device Name MR Conditional Sticky Pad Electrode
Applicant
Rhythmlink International, LLC
1140 First St. S.
Columbia,  SC  29209
Applicant Contact Gabriel Orsinger
Correspondent
Rhythmlink International, LLC
1140 First St. S.
Columbia,  SC  29209
Correspondent Contact Gabriel Orsinger
Regulation Number882.1320
Classification Product Code
GXY  
Date Received10/13/2020
Decision Date 02/09/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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