Philips IntelliVue GuardianSoftware

Display, Cathode-ray Tube, Medical

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 Philips Intellivue Guardiansoftware.

Pre-market Notification Details

Device IDK161767
510k NumberK161767
Device Name:Philips IntelliVue GuardianSoftware
ClassificationDisplay, Cathode-ray Tube, Medical
Applicant PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH HEWLETT-PACKARD STR. 2 Boeblingen,  DE 71034
ContactMichael Asmalsky
CorrespondentMichael Asmalsky
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH HEWLETT-PACKARD STR. 2 Boeblingen,  DE 71034
Product CodeDXJ  
Subsequent Product CodeDQK
Subsequent Product CodeNSX
Subsequent Product CodeOUG
CFR Regulation Number870.2450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-06-27
Decision Date2017-01-27
Summary:summary

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