[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: 21CFR870.2340]

[Page 296]
 
                        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. 870.2340  Electrocardiograph.

    (a) Identification. An electrocardiograph is a device used to 
process the electrical signal transmitted through two or more 
electrocardiograph electrodes and to produce a visual display of the 
electrical signal produced by the heart.
    (b) Classification. Class II (performance standards).