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K Number
K010318
Device Name
PRIMA OXYGEN MONITOR
Manufacturer
PENLON LTD.
Date Cleared
2001-07-23

(171 days)

Product Code
CCL
Regulation Number
868.1720
Type
Traditional
Panel
Anesthesiology
Reference & Predicate Devices
N/A
Predicate For
K051222
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis 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).