[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: 21CFR868.1965]

[Page 274-275]
 
                        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 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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. The 
device is also exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of

[[Page 275]]

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]