END TIDAL CO2 NASAL CANNULA

Analyzer, Gas, Carbon-dioxide, Gaseous-phase

CAREFUSION

The following data is part of a premarket notification filed by Carefusion with the FDA for End Tidal Co2 Nasal Cannula.

Pre-market Notification Details

Device IDK120518
510k NumberK120518
Device Name:END TIDAL CO2 NASAL CANNULA
ClassificationAnalyzer, Gas, Carbon-dioxide, Gaseous-phase
Applicant CAREFUSION 1500 WAUKEGAN ROAD Waukegan,  IL  60085
ContactErika Fernandez
CorrespondentErika Fernandez
CAREFUSION 1500 WAUKEGAN ROAD Waukegan,  IL  60085
Product CodeCCK  
CFR Regulation Number868.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-02-21
Decision Date2012-05-04
Summary:summary

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