MODELS M1175A & M1176A COMPONENT MONITORING SYSTEM
Device Facts
| Record ID | K882609 |
|---|---|
| Device Name | MODELS M1175A & M1176A COMPONENT MONITORING SYSTEM |
| Applicant | Waltham Div. Hewlett Packard |
| Product Code | DRT · Cardiovascular |
| Decision Date | Jan 19, 1989 |
| 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.
