9267 SPO2 ATHENA MODULE

Oximeter

S & W MEDICO TEKNIK

The following data is part of a premarket notification filed by S & W Medico Teknik with the FDA for 9267 Spo2 Athena Module.

Pre-market Notification Details

Device IDK940933
510k NumberK940933
Device Name:9267 SPO2 ATHENA MODULE
ClassificationOximeter
Applicant S & W MEDICO TEKNIK HERSTEDVANG 8 DK-2620 ALBERTSLUND Denmark,  DK
ContactMorten Nielsen
CorrespondentMorten Nielsen
S & W MEDICO TEKNIK HERSTEDVANG 8 DK-2620 ALBERTSLUND Denmark,  DK
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-02-28
Decision Date1995-11-29

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