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) > 868.5895—Continuous ventilator.

868.5895—Continuous ventilator.

(a) Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.
(b) Classification. Class II (performance standards).