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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 K931430
Device Name CUTANEOUS ELECTRODE
Applicant
Medicotest, Inc.
One Metropolitan Sq.
211 N. Broadway, Suite 3600
St. Louis,  MO  63102
Applicant Contact RANDY MARIANI
Correspondent
Medicotest, Inc.
One Metropolitan Sq.
211 N. Broadway, Suite 3600
St. Louis,  MO  63102
Correspondent Contact RANDY MARIANI
Regulation Number882.1320
Classification Product Code
GXY  
Date Received03/22/1993
Decision Date 12/21/1993
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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