---
kind: "section"
citation: "21 C.F.R. § 880.5400"
title: "21"
number: "880.5400"
heading: "Neonatal incubator."
url: "https://uscodex.org/cfr/21/880.5400"
---

# §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).

## Notes

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 45 FR 69682, Oct. 21, 1980, unless otherwise noted.