CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 870—CARDIOVASCULAR DEVICES > SUBPART B—Cardiovascular Diagnostic Devices (§870.1025 to §870.1915) > 870.1435—Single-function, preprogrammed diagnostic computer.

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).