21 CFR 868.1670 — Analyzer, Gas, Neon, Gaseous-Phase

Anesthesiology (AN) · Part 868 Subpart B—Diagnostic Devices · § 868.1670

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).

Product Codes

Product CodeDevice NameClassDevicesAttributes
JEFAnalyzer, Gas, Neon, Gaseous-Phase203rd Party
Innolitics

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