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K Number
K000664
Device Name
VIGILANCE CCO/CEDV & VIGILANCE CCO/SVO2/CEDV MONITORS
Manufacturer
BAXTER HEALTHCARE CORP.
Date Cleared
2000-09-20

(205 days)

Product Code
DXG
Regulation Number
870.1435
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 870.1435 Single-function, preprogrammed diagnostic computer.

(a)
Identification. A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.(b)
Classification. Class II (performance standards).