SERVOMED OXCARDIORE SPIROGRAPH 324/111
Device Facts
| Record ID | K840832 |
|---|---|
| Device Name | SERVOMED OXCARDIORE SPIROGRAPH 324/111 |
| Applicant | Litton Medical Electronics |
| Product Code | DRT · Cardiovascular |
| Decision Date | Sep 20, 1984 |
| 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.
