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FDA 510(k)

Philips IntelliVue GuardianSoftware

K-Number: K161767 · 2017-01-27

ApplicantPhilips Medizin Systeme Boeblingen GmbH
Decision Date2017-01-27
Product CodeDXJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Philips IntelliVue GuardianSoftware is a medical device manufactured by Philips Medizin Systeme Boeblingen GmbH. It received FDA 510(k) clearance on 2017-01-27 under approval number K161767. The device is classified under product code DXJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Philips IntelliVue GuardianSoftware?

Philips IntelliVue GuardianSoftware is a medical device that received FDA 510(k) clearance on 2017-01-27. It is manufactured by Philips Medizin Systeme Boeblingen GmbH. The 510(k) number is K161767.

When was Philips IntelliVue GuardianSoftware approved by the FDA?

Philips IntelliVue GuardianSoftware received FDA 510(k) clearance on 2017-01-27, under approval number K161767.

What company makes Philips IntelliVue GuardianSoftware?

Philips IntelliVue GuardianSoftware is manufactured by Philips Medizin Systeme Boeblingen GmbH.

What is the FDA product code for Philips IntelliVue GuardianSoftware?

The FDA product code for Philips IntelliVue GuardianSoftware is DXJ.

Other Devices by Philips Medizin Systeme Boeblingen GmbH

K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2; IntelliVue Patient Monitors MP20, MP30, MP40, MP50, MP60; IntelliVue Patient Monitors MP70, MP80, MP90;IntelliVue Patient Monitors MX400, MX430, MX450, MX500, MX550, MX600;IntelliVue Patient Monitors MX700, MX800 K172904IntelliVue Capnography Extension, IntelliVue Microstream Extension K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable K181831IntelliVue Multi-Measurement Module MMX K173941IntelliSpace Perinatal Rev.K.00 K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension

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Related Devices (Code: DXJ)

K162012CARESCAPE Central Station V2GE Healthcare K170460Sorin ConnectSorin Group Deutschland GmbH K170537Nexxis OR, NexxisBarco N.V. K161880NIVR58-T kitBarco N.V. K173107Vios Central Station Monitor Software, Vios Central Server SoftwareVios Medical, Inc. K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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