The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Reveal Xt; Insertable Cardiac Monitor (model 9529), Patient Assistant (model 9539).
| Device ID | K071641 |
| 510k Number | K071641 |
| Device Name: | REVEAL XT; INSERTABLE CARDIAC MONITOR (MODEL 9529), PATIENT ASSISTANT (MODEL 9539) |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | MEDTRONIC INC. 8200 CORAL SEA STREET NW Mounds View, MN 55112 |
| Contact | Michelle Nivala |
| Correspondent | Michelle Nivala MEDTRONIC INC. 8200 CORAL SEA STREET NW 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 | 2007-06-15 |
| Decision Date | 2007-11-21 |
| Summary: | summary |