IntelliVue Capnography Extension, IntelliVue Microstream Extension

Analyzer, Gas, Carbon-dioxide, Gaseous-phase

Philips Medizin Systeme Boeblingen GmbH

The following data is part of a premarket notification filed by Philips Medizin Systeme Boeblingen Gmbh with the FDA for Intellivue Capnography Extension, Intellivue Microstream Extension.

Pre-market Notification Details

Device IDK172904
510k NumberK172904
Device Name:IntelliVue Capnography Extension, IntelliVue Microstream Extension
ClassificationAnalyzer, Gas, Carbon-dioxide, Gaseous-phase
Applicant Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str.-2 Boeblingen,  DE 71034
ContactMarkus Stacha
CorrespondentMarkus Stacha
Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str.-2 Boeblingen,  DE 71034
Product CodeCCK  
Subsequent Product CodeBZQ
Subsequent Product CodeDRQ
Subsequent Product CodeDSA
Subsequent Product CodeDXG
Subsequent Product CodeFLL
CFR Regulation Number868.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-22
Decision Date2017-12-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838083585 K172904 000
00884838083578 K172904 000

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