[Title 21 CFR 870.2300]
[Code of Federal Regulations (annual edition) - April 1, 1996 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION,]
[Part 870 - CARDIOVASCULAR DEVICES]
[Subpart C - Cardiovascular Monitoring Devices]
[Sec. 870.2300 - Cardiac monitor (including cardiotachometer and rate alarm).]
[From the U.S. Government Publishing Office]




  21
  FOOD AND DRUGS
  8
  1996-04-01
  1996-04-01
  false
  
  870.2300
  Sec. 870.2300
  
    FOOD AND DRUGS
    FOOD AND DRUG ADMINISTRATION,
    CARDIOVASCULAR DEVICES
    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).

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