21 CFR 868.5270 — Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5270

Identification

A breathing system heater is a device that is intended to warm breathing gases before they enter a patient's airway. The device may include a temperature controller.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer2453rd Party
Innolitics

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