21 CFR 868.5710 — Tent, Oxygen, Electrically Powered

Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5710

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.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
BYKTent, Oxygen, Electrically Powered23Life-Sustaining
FNCTent, Pediatric Aerosol21
Innolitics

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