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FDA 510(k)

Philips IntelliVue GuardianSoftware

K-Number: K180534 · 2018-07-16

ApplicantPhilips Medizin Systeme Boeblingen GmbH
Decision Date2018-07-16
Product CodeDXJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Philips IntelliVue GuardianSoftware is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medizin Systeme Boeblingen GmbH. It received FDA 510(k) clearance on 2018-07-16 under 510(k) number K180534. 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 2018-07-16. The listed applicant is Philips Medizin Systeme Boeblingen GmbH. The 510(k) number is K180534.

When did Philips IntelliVue GuardianSoftware receive FDA 510(k) clearance?

Philips IntelliVue GuardianSoftware received FDA 510(k) clearance on 2018-07-16, under 510(k) number K180534.

Who is the listed applicant for Philips IntelliVue GuardianSoftware?

The FDA 510(k) record lists Philips Medizin Systeme Boeblingen GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Philips IntelliVue GuardianSoftware?

The FDA product code for Philips IntelliVue GuardianSoftware is DXJ.

Other records listing Philips Medizin Systeme Boeblingen GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036)K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550K233440Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341)K231671IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470), IntelliVue 4-Slot Module Rack FMX-4 (866468)K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (866064), IntelliVue Patient Monitor MX550 (866066)

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Related Devices (Code: DXJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K212003ESSENZ Patient MonitorLivanova Deutschland, GmbHK212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbHK201162Essence 55SP Large Monitor SystemShenyang Torch-Bigtide Digital Technology Co., Ltd.K173107Vios Central Station Monitor Software, Vios Central Server SoftwareVios Medical, Inc.K173381Nexxis ORBarco N.V.K172969Essence 55S Large Monitor SystemShenyang Torch-Bigtide Digital Technology Co., Ltd.

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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