21 C.F.R. § 880.5400

Current through September 30, 2024
Section 880.5400 - Neonatal incubator
(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