[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: 21CFR870.2390]

[Page 308]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 870--CARDIOVASCULAR DEVICES--Table of Contents
 
              Subpart C--Cardiovascular Monitoring Devices
 
Sec. 870.2390  Phonocardiograph.

    (a) Identification. A phonocardiograph is a device used to amplify 
or condition the signal from a heart sound transducer. This device 
furnishes the excitation energy for the transducer and provides a visual 
or audible display of the heart sounds.
    (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. 870.9.

[45 FR 7907-7971, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996; 
66 FR 38796, July 25, 2001]