21 C.F.R. § 870.1435

Current through October 31, 2024
Section 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).

21 C.F.R. § 870.1435