PULSE HEART RATE MONITOR
Device Facts
| Record ID | K943243 |
|---|---|
| Device Name | PULSE HEART RATE MONITOR |
| Applicant | Sensor Dynamics, Inc. |
| Product Code | DRT · Cardiovascular |
| Decision Date | Mar 10, 1995 |
| 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.
