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§ 880.5400 Neonatal incubator.

21 CFR 880.5400

Citation21 CFR 880.5400
CorpusDaily eCFR
Displayed edition2026-04-27
Last updated2026-04-27

§ 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).