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) > 868.5160—Gas machine for anesthesia or analgesia.

868.5160—Gas machine for anesthesia or analgesia.

(a) Gas machine for anesthesia— (1) Identification. A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply.
(2) Classification. Class II (performance standards).
(b) Gas machine for analgesia— (1) Identification. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).
(2) Classification. Class II (performance standards).