SIRECUST MODEL 960 AND 961 PATIENT MONITORING
Device Facts
| Record ID | K872249 |
|---|---|
| Device Name | SIRECUST MODEL 960 AND 961 PATIENT MONITORING |
| Applicant | Medical Electronics Laboratories, Inc. |
| Product Code | DRT · Cardiovascular |
| Decision Date | Jul 21, 1987 |
| 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.
