Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector

Analyzer, Gas, Carbon-dioxide, Gaseous-phase

Covidien

The following data is part of a premarket notification filed by Covidien with the FDA for Nellcor Easycap Ii Adult Colorimetric Co2 Detector, Nellcor Pedcicap Pediatric Colorimetric Co2 Detector.

Pre-market Notification Details

Device IDK203762
510k NumberK203762
Device Name:Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector
ClassificationAnalyzer, Gas, Carbon-dioxide, Gaseous-phase
Applicant Covidien 6135 Gunbarrel Ave Boulder,  CO  80301
ContactAshley Johnston
CorrespondentAshley Johnston
Covidien 6135 Gunbarrel Ave Boulder,  CO  80301
Product CodeCCK  
CFR Regulation Number868.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-23
Decision Date2021-09-17

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