[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: 21CFR880.2900]

[Page 394]
 
                        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. 880.2900  Clinical color change thermometer.

    (a) Identification. A clinical color change thermometer is a 
disposable device used to measure a patient's oral, rectal, or axillary 
(armpit) body temperature. The device records body temperature by use of 
heat sensitive chemicals which are sealed at the end of a plastic or 
metal strip. Body heat causes a stable color change in the heat 
sensitive chemicals.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 880.9.

[45 FR 69682-69737, Oct. 21, l980, as amended at 61 FR 1123, Jan. 16, 
1996; 66 FR 38804, July 25, 2001]