21 CFR § 870.1425 Cardiovascular Devices

§ 870.1425 Programmable diagnostic computer.

Current through Sep 8, 2026 · Read all of Part 870

⚠ 3 pending changes to Part 870

(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).

← § 870.1420 Coronary artery disease risk indicator using acoustic heart signals.§ 870.1435 Single-function, preprogrammed diagnostic computer. →