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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 K871668
Device Name BIODAN TYPE COMET ELECTRODE
Applicant
National Medical Technology
436 Rue St-Helene
Suite 102, Montreal
Quebec, Canada,  CA H2Y 2K7
Applicant Contact GEOFFREY R EISELE
Correspondent
National Medical Technology
436 Rue St-Helene
Suite 102, Montreal
Quebec, Canada,  CA H2Y 2K7
Correspondent Contact GEOFFREY R EISELE
Regulation Number870.2360
Classification Product Code
DRX  
Date Received04/28/1987
Decision Date 06/10/1987
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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