JEF · Analyzer, Gas, Neon, Gaseous-Phase

Anesthesiology · 21 CFR 868.1670 · Class 2

Overview

Product CodeJEF
Device NameAnalyzer, Gas, Neon, Gaseous-Phase
Regulation21 CFR 868.1670
Device ClassClass 2
Review PanelAnesthesiology
3rd-Party ReviewableYes

Identification

A neon gas analyzer is a device intended to measure the concentration of neon in a gas mixture exhaled by a patient. The device may use techniques such as mass spectrometry or thermal conductivity.

Classification Rationale

Class II (performance standards).

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Innolitics

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