CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 868—ANESTHESIOLOGY DEVICES > SUBPART F—Therapeutic Devices (§868.5090 to §868.5995) > 868.5270—Breathing system heater.

868.5270—Breathing system heater.

(a) 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.
(b) Classification. Class II (performance standards).