TYPE 9293 INTERFACE PULSEOX

Oximeter

S & W MEDICO TEKNIK

The following data is part of a premarket notification filed by S & W Medico Teknik with the FDA for Type 9293 Interface Pulseox.

Pre-market Notification Details

Device IDK896738
510k NumberK896738
Device Name:TYPE 9293 INTERFACE PULSEOX
ClassificationOximeter
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 CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-11-30
Decision Date1990-08-14

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