KENDALL CO2NFIRM NOW CO2 DETECTOR

Tubes, Gastrointestinal (and Accessories)

KENDALL

The following data is part of a premarket notification filed by Kendall with the FDA for Kendall Co2nfirm Now Co2 Detector.

Pre-market Notification Details

Device IDK042572
510k NumberK042572
Device Name:KENDALL CO2NFIRM NOW CO2 DETECTOR
ClassificationTubes, Gastrointestinal (and Accessories)
Applicant KENDALL 15 HAMPSHIRE ST. Mansfield,  MA  02048
ContactBridget Gardner
CorrespondentBridget Gardner
KENDALL 15 HAMPSHIRE ST. Mansfield,  MA  02048
Product CodeKNT  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-09-21
Decision Date2004-11-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20884521000275 K042572 000
20884521724126 K042572 000
10884521619678 K042572 000

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