Title 21: Food and Drugs
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/ PART 880 - GENERAL HOSPITAL AND PERSONAL USE DEVICES
/ Subpart F - General Hospital and Personal Use Therapeutic Devices / § 880.5400 Neonatal incubator.
§ 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).