21 CFR 868.1120 — Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling

Anesthesiology (AN) · Part 868 Subpart B—Diagnostic Devices · § 868.1120

Identification

An indwelling blood oxyhemoglobin concentration analyzer is a photoelectric device used to measure, in vivo, the oxygen-carrying capacity of hemoglobin in blood to aid in determining the patient's physiological status.

Classification Rationale

Class III (premarket approval).

Product Codes

Product CodeDevice NameClassDevicesAttributes
JEDAnalyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling30
Innolitics

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