§ 870.1435. Single-function, preprogrammed diagnostic computer.
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/us/cfr/t21/s§ 870.1435·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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).