CARDIO REVUE CENTER
Device Facts
| Record ID | K820820 |
|---|---|
| Device Name | CARDIO REVUE CENTER |
| Applicant | Diasonics, Inc. |
| Product Code | DXG · Cardiovascular |
| Decision Date | Apr 29, 1982 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1435 |
| Device Class | Class 2 |
Regulatory Classification
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.
