Code of Federal Regulations (Last Updated: November 8, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter H - Medical Devices |
Part 880 - General Hospital and Personal Use Devices |
Subpart F - General Hospital and Personal Use Therapeutic Devices |
§ 880.5400 - Neonatal incubator.
Latest version.
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§ 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).