[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR870.1425]

[Page 319]
 
                        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. 870.1425  Programmable diagnostic computer.

    (a) Identification. A programmable diagnostic computer is a device 
that can be programmed to compute various physiologic or blood flow 
parameters based on the output from one or more electrodes, transducers, 
or measuring devices; this device includes any associated commercially 
supplied programs.
    (b) Classification. Class II (performance standards).