21 C.F.R. § 880.5400

Neonatal incubator.

Last amended: 2016Year: 2026Length: 70 wordsSubsections: 2Official source

Cite as 21 C.F.R. § 880.5400 (2026)

(a) Identification. A neonatal incubator is a device consisting of a rigid boxlike enclosure in which an infant may be kept in a controlled environment for medical care. The device may include an AC-powered heater, a fan to circulate the warmed air, a container for water to add humidity, a control valve through which oxygen may be added, and access ports for nursing care. (b) Classification. Class II (performance standards).
21 C.F.R. § 880.5400: Neonatal incubator. | Justis AI