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Title 21 Part 880 → Subpart F → §880.5400

Title 21 → Chapter I → Subchapter H → Part 880 → Subpart F → §880.5400

Electronic Code of Federal Regulations e-CFR

Title 21 Part 880 → Subpart F → §880.5400

e-CFR data is current as of July 17, 2019

Title 21Chapter ISubchapter HPart 880Subpart F → §880.5400


Title 21: Food and Drugs
PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES
Subpart F—General Hospital and Personal Use Therapeutic Devices


§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).