THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2

Computer, Diagnostic, Pre-programmed, Single-function

AMERICAN EDWARDS LABORATORIES

The following data is part of a premarket notification filed by American Edwards Laboratories with the FDA for Thermodilution Cardiac Output Computer, Mod. Com-2.

Pre-market Notification Details

Device IDK872529
510k NumberK872529
Device Name:THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2
ClassificationComputer, Diagnostic, Pre-programmed, Single-function
Applicant AMERICAN EDWARDS LABORATORIES P.O. BOX 11150 17221 RED HILL AVE.(IRVINE) Santa Ana,  CA  92711 -1150
ContactHayim Zadaca
CorrespondentHayim Zadaca
AMERICAN EDWARDS LABORATORIES P.O. BOX 11150 17221 RED HILL AVE.(IRVINE) Santa Ana,  CA  92711 -1150
Product CodeDXG  
CFR Regulation Number870.1435 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-06-26
Decision Date1987-09-15

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