U.S. Code of Federal Regulations

Regulations most recently checked for updates: Aug 28, 2025

Searching within: All TitlesTitle 21Chapter IPart 880Subpart F - Subpart F—General Hospital and Personal Use Therapeutic Devices
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§ 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).