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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Needle
510(k) Number K200984
Device Name Guardian Needle 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 Number882.1350
Classification Product Code
GXZ  
Date Received04/14/2020
Decision Date 05/27/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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