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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 K920264
Device Name BIO-DETEK TRACERITE EEG ELECTRODE
Applicant
Bio-Detek, Inc.
453 S. Main St.,
P.O. Box 898
Attleboro,  MA  02703
Applicant Contact MICHAEL R DUPELLE
Correspondent
Bio-Detek, Inc.
453 S. Main St.,
P.O. Box 898
Attleboro,  MA  02703
Correspondent Contact MICHAEL R DUPELLE
Regulation Number882.1320
Classification Product Code
GXY  
Date Received01/21/1992
Decision Date 06/02/1992
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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