[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR868.2300]

[Page 275]
 
                        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. 868.2300  Bourdon gauge flowmeter.

    (a) Identification. A bourdon gauge flowmeter is a device intended 
for medical purposes that is used in conjunction with respiratory 
equipment to sense gas pressure. The device is calibrated to indicate 
gas flow rate when the outflow is open to the atmosphere.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996]