21 CFR §868.5160

1. (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.
   1. (2)Classification. Class II (performance standards).
2. (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).
   1. (2)Classification. Class II (performance standards).