 |
Code of Federal Regulations (Last Updated: July 5, 2024) |
 |
Title 21 - Food and Drugs |
|
Chapter I - Food and Drug Administration, Department of Health and Human Services |
|
SubChapter H - Medical Devices |
|
Part 870 - Cardiovascular Devices |
|
Subpart B - Cardiovascular Diagnostic Devices |
§ 870.1435 - Single-function, preprogrammed diagnostic computer.
Latest version.
-
§ 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).