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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 K971914
Device Name TECA NCS ELECTRODE SYSTEM 2000
Applicant
Medelec, Inc. D.B.A. Teca Corp.
3 Campus Dr.
Pleasantville,  NY  10570
Applicant Contact JAMES P HURLMAN
Correspondent
Medelec, Inc. D.B.A. Teca Corp.
3 Campus Dr.
Pleasantville,  NY  10570
Correspondent Contact JAMES P HURLMAN
Regulation Number882.1320
Classification Product Code
GXY  
Date Received05/23/1997
Decision Date 03/26/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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