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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 K091856
Device Name CONMED ECG MONITORING ELECTRODES , MODEL 1700 ( INCLUDING 2500), 1750, 2700, 2710, 1800, SERIES
Applicant
Conmed Corporation
525 French Rd.
Utica,  NY  13502
Applicant Contact SANDRA COVELESKI
Correspondent
Conmed Corporation
525 French Rd.
Utica,  NY  13502
Correspondent Contact SANDRA COVELESKI
Regulation Number870.2360
Classification Product Code
DRX  
Date Received06/23/2009
Decision Date 08/07/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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