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Title 21 Part 880 → Subpart F → §880.5410

Title 21 → Chapter I → Subchapter H → Part 880 → Subpart F → §880.5410

Electronic Code of Federal Regulations e-CFR

Title 21 Part 880 → Subpart F → §880.5410

e-CFR data is current as of June 18, 2019

Title 21Chapter ISubchapter HPart 880Subpart F → §880.5410


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


§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).