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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrocardiograph
510(k) Number K853038
Device Name DE12 RAPID TRACE AT-REST DIAGNOSTIC ECG ELECTRODES
Applicant
Bio-Detek, Inc.
171 Forbes Blvd.
P.O. Box 809
Mansfield,  MA  02048
Applicant Contact DONALD C EPSTEIN
Correspondent
Bio-Detek, Inc.
171 Forbes Blvd.
P.O. Box 809
Mansfield,  MA  02048
Correspondent Contact DONALD C EPSTEIN
Regulation Number870.2360
Classification Product Code
DRX  
Date Received07/19/1985
Decision Date 01/07/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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