ADVANCEMED HOLTER RECORDERS
Device Facts
| Record ID | K803224 |
|---|---|
| Device Name | ADVANCEMED HOLTER RECORDERS |
| Applicant | American Edwards Laboratories |
| Product Code | DSH · Cardiovascular |
| Decision Date | Jan 13, 1981 |
| 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.
