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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 K020382
Device Name BLUE SENSOR, DISPOSABLE ECG ELECTRODES FOR ANAESTHESIA
Applicant
Medicotest A/S
1800 Masschusetts Ave., NW
Suite 200
Washington,  DC  20036
Applicant Contact EMALEE G MURPHY
Correspondent
Medicotest A/S
1800 Masschusetts Ave., NW
Suite 200
Washington,  DC  20036
Correspondent Contact EMALEE G MURPHY
Regulation Number870.2360
Classification Product Code
DRX  
Date Received02/05/2002
Decision Date 06/28/2002
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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