8100 VITAL SIGNS MONITOR
Device Facts
| Record ID | K001020 |
|---|---|
| Device Name | 8100 VITAL SIGNS MONITOR |
| Applicant | Criticare Systems, Inc. |
| Product Code | MWI · Cardiovascular |
| Decision Date | Apr 28, 2000 |
| Decision | SESE |
| Submission Type | Special |
| 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.
