Philips IntelliVue GuardianSoftware (Rev. E.0X)

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 (rev. E.0x).

Pre-market Notification Details

Device IDK212208
510k NumberK212208
Device Name:Philips IntelliVue GuardianSoftware (Rev. E.0X)
ClassificationDisplay, Cathode-ray Tube, Medical
Applicant Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard Str. 2 Boeblingen,  DE 71034
ContactJohannes Schmid
CorrespondentPrithul Bom
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeDXJ  
CFR Regulation Number870.2450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2021-07-15
Decision Date2021-09-30

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