21 C.F.R. § 868.5710

Current through April 30, 2024
Section 868.5710 - Electrically powered oxygen tent
(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).

21 C.F.R. § 868.5710