21 CFR 870.1435 — Computer, Diagnostic, Pre-Programmed, Single-Function
Cardiovascular (CV) · Part 870 Subpart B—Cardiovascular Diagnostic Devices · § 870.1435
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.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 2 | 177 | 3rd Party |
