CRITIKON CARDIAC OUTPUT COMPUTER W/HEMODYNAMIC
Device Facts
| Record ID | K844116 |
|---|---|
| Device Name | CRITIKON CARDIAC OUTPUT COMPUTER W/HEMODYNAMIC |
| Applicant | Critikon Company, LLC |
| Product Code | DXG · Cardiovascular |
| Decision Date | May 28, 1985 |
| 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.
