FDA 510(k)

Philips IntelliVue GuardianSoftware (Rev. E.0X)

K-Number: K212208 · 2021-09-30

ApplicantPhilips Medizin Systeme Boeblingen GmbH

Decision Date2021-09-30

Product CodeDXJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Philips IntelliVue GuardianSoftware (Rev. E.0X) is a medical device manufactured by Philips Medizin Systeme Boeblingen GmbH. It received FDA 510(k) clearance on 2021-09-30 under approval number K212208. 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 (Rev. E.0X)?

Philips IntelliVue GuardianSoftware (Rev. E.0X) is a medical device that received FDA 510(k) clearance on 2021-09-30. It is manufactured by Philips Medizin Systeme Boeblingen GmbH. The 510(k) number is K212208.

When was Philips IntelliVue GuardianSoftware (Rev. E.0X) approved by the FDA?

Philips IntelliVue GuardianSoftware (Rev. E.0X) received FDA 510(k) clearance on 2021-09-30, under approval number K212208.

What company makes Philips IntelliVue GuardianSoftware (Rev. E.0X)?

Philips IntelliVue GuardianSoftware (Rev. E.0X) is manufactured by Philips Medizin Systeme Boeblingen GmbH.

What is the FDA product code for Philips IntelliVue GuardianSoftware (Rev. E.0X)?

The FDA product code for Philips IntelliVue GuardianSoftware (Rev. E.0X) 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 K161767Philips IntelliVue GuardianSoftware K181831IntelliVue Multi-Measurement Module MMX K173941IntelliSpace Perinatal Rev.K.00

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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. K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH K173107Vios Central Station Monitor Software, Vios Central Server SoftwareVios Medical, Inc.

Official Source

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