Vigilance II Continuous Cardiac Output/Oximetry/Volumetric Monitor, Model VIG2

Q: What is the product code of K043103?

The FDA product code is DXG – Computer, Diagnostic, Pre-Programmed, Single-Function, a Class II (moderate risk) device regulated under 21 CFR 870.1435.

FDA 510(k) K043103 · Edwards Lifesciences, LLC

Substantially Equivalent

510(k) numberK043103

Submission

Device name: Vigilance II Continuous Cardiac Output/Oximetry/Volumetric Monitor, Model VIG2
Applicant: Edwards Lifesciences, LLC
Irvine, CA, US
Received: November 9, 2004
Decision date: December 9, 2004
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: DXG – Computer, Diagnostic, Pre-Programmed, Single-Function
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.1435
Specialty: Cardiovascular

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Questions and answers

When was Vigilance II Continuous Cardiac Output/Oximetry/Volumetric Monitor, Model VIG2 cleared by the FDA?

Vigilance II Continuous Cardiac Output/Oximetry/Volumetric Monitor, Model VIG2 (K043103) received a 510(k) decision of Substantially Equivalent on December 9, 2004, 30 days after the submission was received.

What is the product code of K043103?

The FDA product code is DXG – Computer, Diagnostic, Pre-Programmed, Single-Function, a Class II (moderate risk) device regulated under 21 CFR 870.1435.