21 CFR § 880.5400 General Hospital and Personal Use Devices

§ 880.5400 Neonatal incubator.

Current through Sep 8, 2026 · Read all of Part 880

(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).

← § 880.5300 Medical absorbent fiber.§ 880.5405 Active noise attenuation system for infant incubators. →