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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 K200540
Device Name BRAINSTREAM Disposable Deep Cup EEG Electrodes
Applicant
Conmed Corporation
525 French Rd.
Utica,  NY  13502
Applicant Contact Tessa Hopsicker
Correspondent
Conmed Corporation
525 French Rd.
Utica,  NY  13502
Correspondent Contact Tessa Hopsicker
Regulation Number882.1320
Classification Product Code
GXY  
Date Received03/03/2020
Decision Date 06/01/2020
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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