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§ 870.1425 Programmable diagnostic computer.

21 CFR 870.1425

Citation21 CFR 870.1425
CorpusDaily eCFR
Displayed edition2026-04-15
Last updated2026-04-15

§ 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).