Title 21

SECTION 870.1435

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).

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