[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: 21CFR880.2200]

[Page 392]
 
                        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 C--General Hospital and Personal Use Monitoring Devices
 
Sec. 880.2200  Liquid crystal forehead temperature strip.


    (a) Identification. A liquid crystal forehead temperature strip is a 
device applied to the forehead that is used to indicate the presence or 
absence of fever, or to monitor body temperature changes. The device 
displays the color changes of heat sensitive liquid crystals 
corresponding to the variation in the surface temperature of the skin. 
The liquid crystals, which are cholesteric esters, are sealed in 
plastic.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 880.9.

[45 FR 69682-69737, Oct. 21, l980, as amended at 63 FR 59228, Nov. 3, 
1998]