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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 K191225
Device Name EEG Electrode Template
Applicant
Rhythmlink International, LLC
1140 First Street South
columbia,  SC  29209
Applicant Contact gabriel orsinger
Correspondent
Rhythmlink International, LLC
1140 First Street South
columbia,  SC  29209
Correspondent Contact gabriel orsinger
Regulation Number882.1320
Classification Product Code
GXY  
Date Received05/07/2019
Decision Date 08/05/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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