TYPE 9292 INTERFACE CAPNOGRAPH

Analyzer, Gas, Carbon-dioxide, Gaseous-phase

S & W MEDICO TEKNIK

The following data is part of a premarket notification filed by S & W Medico Teknik with the FDA for Type 9292 Interface Capnograph.

Pre-market Notification Details

Device IDK896737
510k NumberK896737
Device Name:TYPE 9292 INTERFACE CAPNOGRAPH
ClassificationAnalyzer, Gas, Carbon-dioxide, Gaseous-phase
Applicant S & W MEDICO TEKNIK HERSTEDVANG 8 DK-2620 ALBERTSLUND Denmark,  DK
ContactLisbeth Isbrandt
CorrespondentLisbeth Isbrandt
S & W MEDICO TEKNIK HERSTEDVANG 8 DK-2620 ALBERTSLUND Denmark,  DK
Product CodeCCK  
CFR Regulation Number868.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-11-30
Decision Date1990-02-28

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