 |
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 |
§ 880.5410 - Neonatal transport incubator.
Latest version.
-
§ 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).