Regulations last checked for updates: Oct 17, 2024

Title 21 - Food and Drugs last revised: Oct 15, 2024
§ 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).

authority: 21 U.S.C. 351,360,360c,360e,360j,360
source: 45 FR 69682, Oct. 21, 1980, unless otherwise noted.
cite as: 21 CFR 880.5400