[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: 21CFR868.1850]

[Page 284]
 
                        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 B--Diagnostic Devices
 
Sec. 868.1850  Monitoring spirometer.

    (a) Identification. A monitoring spirometer is a device used to 
measure continuously a patient's tidal volume (volume of gas inhaled by 
the patient during each respiration cycle) or minute volume (the tidal 
volume multiplied by the rate of respiration for 1 minute) for the 
evaluation of the patient's ventilatory status.
    (b) Classification. Class II (performance standards).