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FDA 510(k)

VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR

K-Number: K062134 · 2006-08-22

ApplicantEdwards Lifesciences, LLC
Decision Date2006-08-22
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2006-08-22 under 510(k) number K062134. The device is classified under product code DXG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR?

VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR is a medical device that received FDA 510(k) clearance on 2006-08-22. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K062134.

When did VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR receive FDA 510(k) clearance?

VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR received FDA 510(k) clearance on 2006-08-22, under 510(k) number K062134.

Who is the listed applicant for VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR?

The FDA 510(k) record lists Edwards Lifesciences, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR?

The FDA product code for VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR is DXG.

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Related Devices (Code: DXG)

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.

K253092Argos Infinity (Rev. 1.0)Retia Medical Systems, Inc.K251275VitalStream ART Connect; VitalStream-HemoCaretaker MedicalK232048Cogent™ Hemodynamic Monitoring System; Cogent™ HMSIcu MedicalK212529Hypotension Decision Assist Model HDA-OR2Directed Systems, Ltd.K192169PulsioFlex Monitoring System with ProAQT SensorPulsion Medical Systems SEK193179EV1000 Clinical PlatformEdwards Lifesciences, LLC

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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