21 C.F.R. § 870.1435 Single-function, preprogrammed diagnostic computer.
Title 21 - Food and Drugs
(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).
Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart B—Cardiovascular Diagnostic Devices
§ 870.1435 Single-function, preprogrammed diagnostic computer.