[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR870.1435]

[Page 298]
 
                        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. 870.1435  Single-function, preprogrammed diagnostic computer.

    (a) Identification. A single-function, preprogrammed diagnostic 
computer is a hard-wired computer that calculates a specific 
physiological or blood-flow parameter based on information obtained from 
one or more electrodes, transducers, or measuring devices.
    (b) Classification. Class II (performance standards).