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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plethysmograph, Impedance
510(k) Number K131765
Device Name ECOM ENDOTRACHEAL CARDIAC OUTPUT MONITOR SYSTEM
Applicant
Conmed Corporation
525 French Rd.
Utica,  NY  13502
Applicant Contact LISA ANDERSON
Correspondent
Conmed Corporation
525 French Rd.
Utica,  NY  13502
Correspondent Contact LISA ANDERSON
Regulation Number870.2770
Classification Product Code
DSB  
Date Received06/17/2013
Decision Date 12/20/2013
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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