SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIA

Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling

S & W MEDICO TEKNIK

The following data is part of a premarket notification filed by S & W Medico Teknik with the FDA for System Athena-product Enhancements, Anesthesia.

Pre-market Notification Details

Device IDK912145
510k NumberK912145
Device Name:SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIA
ClassificationAnalyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling
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 CodeCCE  
CFR Regulation Number868.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-04-09
Decision Date1992-05-05

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