SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A
Device Facts
| Record ID | K101968 |
|---|---|
| Device Name | SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A |
| Applicant | St Jude Medical |
| Product Code | MXC · Cardiovascular |
| Decision Date | Sep 15, 2010 |
| 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.
