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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 K970639
Device Name NEUROLINE, DISPOSABLE REFERENCE AND RECORDING ELECTRODES TYPE NO: 72000-S, 72010-K
Applicant
Medicotest, Inc.
1900 K St. NW
Washington,  DC  20006
Applicant Contact EMALEE G MURPHY
Correspondent
Medicotest, Inc.
1900 K St. NW
Washington,  DC  20006
Correspondent Contact EMALEE G MURPHY
Regulation Number882.1320
Classification Product Code
GXY  
Date Received02/20/1997
Decision Date 05/15/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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