[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: 21CFR870.1875]

[Page 306]
 
                        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 B--Cardiovascular Diagnostic Devices
 
Sec. 870.1875  Stethoscope.

    (a) Manual stethoscope--(1) Identification. A manual stethoscope is 
a mechanical device used to project the sounds associated with the 
heart, arteries, and veins and other internal organs.
    (2) 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.
    (b) Electronic stethoscope--(1) Identification. An electronic 
stethoscope is an electrically amplified device used to project the 
sounds associated with the heart, arteries, and veins and other internal 
organs.
    (2) Classification. Class II (performance standards).

[45 FR 7907-7971, Feb. 5, 1980, as amended at 59 FR 63007, Dec. 7, 1994; 
66 FR 38796, July 25, 2001]