21 CFR 870.1425

§ 870.1425 Programmable diagnostic computer.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 870.1425, § 870.1425 Programmable diagnostic computer, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89900
Permanent ID: ys:prov:89900@1
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Full text

(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).

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.