MODEL 556 MONITOR W/24-HR. TREND RECALL/MODIFIED
Device Facts
| Record ID | K910665 |
|---|---|
| Device Name | MODEL 556 MONITOR W/24-HR. TREND RECALL/MODIFIED |
| Applicant | Ge Medical Systems Information Technologies |
| Product Code | DRT · Cardiovascular |
| Decision Date | Dec 31, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2300 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.
