[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR880.5410]

[Page 398]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES--Table of Contents
 
    Subpart F--General Hospital and Personal Use Therapeutic Devices
 
Sec. 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).