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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 K981964
Device Name MEDI-TRACE 4103 NEONATAL ELECTRODE
Applicant
Graphic Controls Corp.
P.O. Box 1274
189 Van Rensselaer St.
Buffalo,  NY  14240
Applicant Contact SUSAN KRASNY
Correspondent
Graphic Controls Corp.
P.O. Box 1274
189 Van Rensselaer St.
Buffalo,  NY  14240
Correspondent Contact SUSAN KRASNY
Regulation Number870.2360
Classification Product Code
DRX  
Date Received06/04/1998
Decision Date 11/13/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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