Neonatal incubator.

21 C.F.R. § 880.5400
in effectEffective: 2024-07-01
Sign in to generate a plain English summaryAsk Belisarius Agent
(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).

Starting a business? Corpus forms LLCs in all 50 states and DC.