[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: 21CFR868.1965]

[Page 299]
 
                        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. 868.1965  Switching valve (ploss).

    (a) Identification. A switching valve (ploss) is a three-way valve 
located between a stethoscope placed over the heart, a blood pressure 
cuff, and an earpiece. The valve allows the user to eliminate one sound 
channel and listen only to a patient's heart or korotkoff (blood 
pressure) sounds through the other channel.
    (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. The device is 
also exempt from the current good manufacturing practice regulations in 
part 820 of this chapter, with the exception of Sec. 820.180, with 
respect to general requirements concerning records, and Sec. 820.198, 
with respect to complaint files.

[47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989; 
66 FR 38793, July 25, 2001]