21 C.F.R. § 880.5410

Current through September 30, 2024
Section 880.5410 - Neonatal transport incubator
(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).

21 C.F.R. § 880.5410