Microstream CO2 NanoPod

Analyzer, Gas, Carbon-dioxide, Gaseous-phase

Covidien LLC

The following data is part of a premarket notification filed by Covidien Llc with the FDA for Microstream Co2 Nanopod.

Pre-market Notification Details

Device IDK213911
510k NumberK213911
Device Name:Microstream CO2 NanoPod
ClassificationAnalyzer, Gas, Carbon-dioxide, Gaseous-phase
Applicant Covidien LLC 6135 Gunbarrel Ave Boulder,  CO  80301
ContactAndrew Berkeland
CorrespondentAndrew Berkeland
Covidien LLC 6135 Gunbarrel Ave Boulder,  CO  80301
Product CodeCCK  
CFR Regulation Number868.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-15
Decision Date2022-07-29

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.