21 C.F.R. § 880.5410 Neonatal transport incubator.
Title 21 - Food and Drugs
(a) Identification. A neonatal transport incubator is a device consisting of a portable rigid boxlike enclosure with insulated walls in which an infant may be kept in a controlled environment while being transported for medical care. The device may include straps to secure the infant, a battery-operated heater, an AC-powered battery charger, a fan to circulate the warmed air, a container for water to add humidity, and provision for a portable oxygen bottle. (b) Classification. Class II (performance standards).
Title 21: Food and Drugs
PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES
Subpart F—General Hospital and Personal Use Therapeutic Devices
§ 880.5410 Neonatal transport incubator.
