The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Sjm Confirm Model Dm2100 Implantable Cardiac Monitor And Model Dm2100a Patient Activator.
| Device ID | K081365 |
| 510k Number | K081365 |
| Device Name: | SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A PATIENT ACTIVATOR |
| Classification | Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection) |
| Applicant | ST. JUDE MEDICAL 701 EAST EVELYN AVENUE Sunnyvale, CA 94086 -6527 |
| Contact | Elizabeth E Neely |
| Correspondent | Elizabeth E Neely ST. JUDE MEDICAL 701 EAST EVELYN AVENUE Sunnyvale, CA 94086 -6527 |
| Product Code | MXC |
| Subsequent Product Code | DSH |
| Subsequent Product Code | DXH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-15 |
| Decision Date | 2008-08-15 |
| Summary: | summary |