21 C.F.R. § 870.1425
Programmable diagnostic computer.
Cite as 21 C.F.R. § 870.1425 (2026)
(a) Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs. (b) Classification. Class II (performance standards).