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§868.5160. Gas machine for anesthesia or analgesia.

21 C.F.R. § 868.5160

(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).
Notes, amendments, and revision history

Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

Source

Source: 47 FR 31142, July 16, 1982, unless otherwise noted.