21 CFR 870.1425 — Computer, Diagnostic, Programmable
Cardiovascular (CV) · Part 870 Subpart B—Cardiovascular Diagnostic Devices · § 870.1425
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.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | 2 | 427 | 3rd Party |
