[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR880.5400]

[Page 389]
 
                        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. 880.5400  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).