[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: 21CFR868.2377]

[Page 286-287]
 
                        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. 868.2377  Apnea monitor.

    (a) Identification. An apnea monitor is a complete system intended 
to alarm primarily upon the cessation of breathing timed from the last 
detected

[[Page 287]]

breath. The apnea monitor also includes indirect methods of apnea 
detection such as monitoring of heart rate and other physiological 
parameters linked to the presence or absence of adequate respiration.
    (b) Classification. Class II (special controls). The special control 
for this device is the FDA guidance document entitled ``Class II Special 
Controls Guidance Document: Apnea Monitors; Guidance for Industry and 
FDA.''

[67 FR 46852, July 17, 2002]