ECOM ENDOTRACHIAL CARDIAC OUTPUT MONITOR


Device Classification Name

plethysmograph, impedance

510(k) Number K021174
Device Name ECOM ENDOTRACHIAL CARDIAC OUTPUT MONITOR
Original Applicant
IMAGYN SURGICAL
8850 m-89
richland, 
MI 
49083

Original Contact julie powell
Regulation Number 870.2770
Classification Product Code
DSB  
Date Received 04/12/2002
Decision Date 04/29/2003
Decision

se – with limitations

(SESU)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No