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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 K983689
Device Name BLUE SENSOR SUPATAB,DISPOSABLE ECG ELECTRODES
Applicant
Medicotest A/S
1900 K St. NW
Washington,  DC  20006
Applicant Contact EMALEE G MURPHY
Correspondent
Medicotest A/S
1900 K St. NW
Washington,  DC  20006
Correspondent Contact EMALEE G MURPHY
Regulation Number870.2360
Classification Product Code
DRX  
Date Received10/20/1998
Decision Date 01/15/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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