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FDA 510(k)

INTELLIVUE CLINICAL INFORMATION PORTFOLIO

K-Number: K100272 · 2010-04-14

ApplicantPhilips Medical Systems
Decision Date2010-04-14
Product CodeDXJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INTELLIVUE CLINICAL INFORMATION PORTFOLIO is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems. It received FDA 510(k) clearance on 2010-04-14 under 510(k) number K100272. 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 INTELLIVUE CLINICAL INFORMATION PORTFOLIO?

INTELLIVUE CLINICAL INFORMATION PORTFOLIO is a medical device that received FDA 510(k) clearance on 2010-04-14. The listed applicant is Philips Medical Systems. The 510(k) number is K100272.

When did INTELLIVUE CLINICAL INFORMATION PORTFOLIO receive FDA 510(k) clearance?

INTELLIVUE CLINICAL INFORMATION PORTFOLIO received FDA 510(k) clearance on 2010-04-14, under 510(k) number K100272.

Who is the listed applicant for INTELLIVUE CLINICAL INFORMATION PORTFOLIO?

The FDA 510(k) record lists Philips Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTELLIVUE CLINICAL INFORMATION PORTFOLIO?

The FDA product code for INTELLIVUE CLINICAL INFORMATION PORTFOLIO is DXJ.

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Other records listing Philips Medical Systems 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.

K212704Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound SystemK211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemK210560Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 CardiographK191738PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph, PageWriter TC70 CardiographK192875Philips Biosensor BX100K183387M3290B Patient Information Center iX

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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.K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbHK173381Nexxis ORBarco N.V.

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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