RADIANALYZER, MODEL 12710
Device Facts
| Record ID | K002067 |
|---|---|
| Device Name | RADIANALYZER, MODEL 12710 |
| Applicant | Radi Medical Systems AB |
| Product Code | DSK · Cardiovascular |
| Decision Date | Jan 11, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1110 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A blood pressure computer is a device that accepts the electrical signal from a blood pressure transducer amplifier and indicates the systolic, diastolic, or mean pressure based on the input signal.