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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 K844856
Device Name ME20 TRACERITE CLEAR VENT TAPE, ME30 TRACERITE NON
Applicant
Bristol Medical Electronics Corp.
171c Forbes Blvd.
P.O. Box 809
Mansfield,  MA  02048
Applicant Contact DONALD C EPSTEIN
Correspondent
Bristol Medical Electronics Corp.
171c Forbes Blvd.
P.O. Box 809
Mansfield,  MA  02048
Correspondent Contact DONALD C EPSTEIN
Regulation Number870.2360
Classification Product Code
DRX  
Date Received12/14/1984
Decision Date 02/20/1985
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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