Programmable diagnostic computer.

21 C.F.R. § 870.1425
in effectEffective: 2024-07-01
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(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).

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