INTELLIVUE CL RESPIRATION POD

Monitor, Breathing Frequency

PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN

The following data is part of a premarket notification filed by Philips Medizinsysteme Boeblingen Gmbh, Cardiac An with the FDA for Intellivue Cl Respiration Pod.

Pre-market Notification Details

Device IDK132320
510k NumberK132320
Device Name:INTELLIVUE CL RESPIRATION POD
ClassificationMonitor, Breathing Frequency
Applicant PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN HEWLETT-PACKARD STR.2 Boeblingen,  DE D 71034
ContactJohannes Schmid
CorrespondentJohannes Schmid
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN HEWLETT-PACKARD STR.2 Boeblingen,  DE D 71034
Product CodeBZQ  
CFR Regulation Number868.2375 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-07-25
Decision Date2014-03-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838020689 K132320 000

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