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K Number
K953795
Device Name
VITALMAX 4100
Manufacturer
PACE TECH, INC.
Date Cleared
1996-07-01

(322 days)

Product Code
CBS
Regulation Number
868.1620
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 868.1620 Halothane gas analyzer.

(a)
Identification. A halothane gas analyzer is a device intended to measure the concentration of halothane anesthetic in a gas mixture. The device may use techniques such as mass spectrometry or absorption of infrared or ultraviolet radiation.(b)
Classification. Class II (performance standards).