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K Number
K943824
Device Name
GASEOUS OXYGEN ANALYZER (MODEL S-3A) MODIFICATION
Manufacturer
AMETEK, INC.
Date Cleared
1996-11-01

(914 days)

Product Code
CCL
Regulation Number
868.1720
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 868.1720 Oxygen gas analyzer.

(a)
Identification. An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory gases by techniques such as mass spectrometry, polarography, thermal conductivity, or gas chromatography. This generic type of device also includes paramagnetic analyzers.(b)
Classification. Class II (performance standards).