Single-function, preprogrammed diagnostic computer.

21 C.F.R. § 870.1435

in effectEffective: 2024-07-01

(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).

Source: eCFRURL: https://www.ecfr.gov/api/versioner/v1/full/2024-07-01/title-21.xmlFetched: 7/26/2026