REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM MODEL 9526 IMPLANTABLE RECORDER AND MODEL 6191 PATIENT ACTIVATOR
Device Facts
| Record ID | K011098 |
|---|---|
| Device Name | REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM MODEL 9526 IMPLANTABLE RECORDER AND MODEL 6191 PATIENT ACTIVATOR |
| Applicant | Medtronic Vascular |
| Product Code | MXC · Cardiovascular |
| Decision Date | May 4, 2001 |
| Decision | SESE |
| Submission Type | Special |
| 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.