§ 870.1435 Single-function, preprogrammed diagnostic computer.
Current through Sep 8, 2026 · Read all of Part 870
(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).