The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Reveal Xt Insertable Cardiac Monitor, Model 9529, Revel Dx Insertable Cardiac Monitor, Model 9528.
| Device ID | K082475 |
| 510k Number | K082475 |
| Device Name: | REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529, REVEL DX INSERTABLE CARDIAC MONITOR, MODEL 9528 |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | MEDTRONIC INC. 8200 CORAL SEA STREET NE MS MV S11 Mounds View, MN 55112 |
| Contact | Debbie Kidder |
| Correspondent | Debbie Kidder MEDTRONIC INC. 8200 CORAL SEA STREET NE MS MV S11 Mounds View, MN 55112 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-28 |
| Decision Date | 2008-11-07 |
| Summary: | summary |