CAPNODURA COMBI & CAPNODURA PEDI CO2 DETECTOR

Analyzer, Gas, Carbon-dioxide, Gaseous-phase

SEEBREATH AB

The following data is part of a premarket notification filed by Seebreath Ab with the FDA for Capnodura Combi & Capnodura Pedi Co2 Detector.

Pre-market Notification Details

Device IDK112840
510k NumberK112840
Device Name:CAPNODURA COMBI & CAPNODURA PEDI CO2 DETECTOR
ClassificationAnalyzer, Gas, Carbon-dioxide, Gaseous-phase
Applicant SEEBREATH AB MORKULLEVAGEN 31 Bjarred,  SE 23736
ContactAnette Sjogren
CorrespondentAnette Sjogren
SEEBREATH AB MORKULLEVAGEN 31 Bjarred,  SE 23736
Product CodeCCK  
CFR Regulation Number868.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-09-29
Decision Date2012-07-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50190752158427 K112840 000

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