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K Number
K002382

Validate with FDA (Live)

Device Name
'ALL 2000' % OXYGEN ANALYZER
Manufacturer
ANALYTICAL INDUSTRIES, INC.
Date Cleared
2001-03-14

(222 days)

Product Code
CCL
Regulation Number
868.1720
Type
Traditional
Panel
Anesthesiology
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K053407
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 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).