21 C.F.R. § 870.1425

Current through November 30, 2024
Section 870.1425 - Programmable diagnostic computer
(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).

21 C.F.R. § 870.1425