[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: 21CFR868.2375]

[Page 279]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 868--ANESTHESIOLOGY DEVICES--Table of Contents
 
                      Subpart C--Monitoring Devices
 
Sec. 868.2375  Breathing frequency monitor.

    (a) Identification. A breathing (ventilatory) frequency monitor is a 
device intended to measure or monitor a patient's respiratory rate. The 
device may provide an audible or visible alarm when the respiratory rate 
is outside predetermined limits.
    (b) Classification. Class II (performance standards).