[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR868.2300]

[Page 299-300]
 
                        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

[[Page 300]]

sense gas pressure. The device is calibrated to indicate gas flow rate 
when the outflow is open to the atmosphere.
    (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. 868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 
FR 38794, July 25, 2001]