---
kind: "section"
citation: "21 C.F.R. § 870.1435"
title: "21"
number: "870.1435"
heading: "Single-function, preprogrammed diagnostic computer."
url: "https://uscodex.org/cfr/21/870.1435"
---

# §870.1435. Single-function, preprogrammed diagnostic computer.

- (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).

## Notes

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 45 FR 7907, Feb. 5, 1980, unless otherwise noted.