EPLAB (ELECTROCARDIOGRAPHIC MONITOR)
Device Facts
| Record ID | K893836 |
|---|---|
| Device Name | EPLAB (ELECTROCARDIOGRAPHIC MONITOR) |
| Applicant | Quinton Electrophysiology Corp. |
| Product Code | DSH · Cardiovascular |
| Decision Date | Sep 8, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2800 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.