21 CFR § 868.5710
Electrically powered oxygen tent
June 25, 2020
(a) Identification. An electrically powered oxygen tent is a device that encloses a patient's head and, by means of an electrically powered unit, administers breathing oxygen and controls the temperature and humidity of the breathing gases. This generic type device includes the pediatric aerosol tent.
(b) Classification. Class II (performance standards).