AIR SHIELDS AS-100 MONIORING SYS-AS105
Device Facts
| Record ID | K831430 |
|---|---|
| Device Name | AIR SHIELDS AS-100 MONIORING SYS-AS105 |
| Applicant | Narco Scientific |
| Product Code | DRT · Cardiovascular |
| Decision Date | Sep 12, 1983 |
| 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.
