510(k) K131765

ECOM ENDOTRACHEAL CARDIAC OUTPUT MONITOR SYSTEM by Conmed Corporation — Product Code DSB

K131765 is an FDA 510(k) premarket notification submitted by Conmed Corporation for the device "ECOM ENDOTRACHEAL CARDIAC OUTPUT MONITOR SYSTEM". The FDA issued a decision of Substantially Equivalent on December 20, 2013. The device falls under product code DSB (Plethysmograph, Impedance), a Class II device regulated under 21 CFR 870.2770. Conmed Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2013
Date Received
June 17, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plethysmograph, Impedance
Device Class
Class II
Regulation Number
870.2770
Review Panel
CV
Submission Type