#505 PORT. VITAL FUNCTIONS NEONATAL MON
Device Facts
| Record ID | K820416 |
|---|---|
| Device Name | #505 PORT. VITAL FUNCTIONS NEONATAL MON |
| Applicant | Ge Medical Systems Information Technologies |
| Product Code | DRT · Cardiovascular |
| Decision Date | Mar 4, 1982 |
| 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.
