[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: 21CFR870.2300]

[Page 307]
 
                        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. 870.2300  Cardiac monitor (including cardiotachometer and rate alarm).

    (a) Identification. A cardiac monitor (including cardiotachometer 
and rate alarm) is a device used to measure the heart rate from an 
analog signal produced by an electrocardiograph, vectorcardiograph, or 
blood pressure monitor. This device may sound an alarm when the heart 
rate falls outside preset upper and lower limits.
    (b) Classification. Class II (performance standards).