21 CFR 870.1435

§ 870.1435 Single-function, preprogrammed diagnostic computer.

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

Cite this

Citation: 21 CFR 870.1435, § 870.1435 Single-function, preprogrammed diagnostic computer, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89901
Permanent ID: ys:prov:89901@1
SHA-256: 62713608379d6e586d868d1e138bfc18228c9cd5edb5c14183cfbf21e65c31af

The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.

Full text

(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).

Legislative history

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