21 CFR 868.5330 — Mixer, Breathing Gases, Anesthesia Inhalation

Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5330

Identification

A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
BZRMixer, Breathing Gases, Anesthesia Inhalation2553rd Party, Life-Sustaining
Innolitics

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