The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Reveal Xt Insertable Cardiac Monitor, Model 9529 And Reveal Dx Insertable Cardiac Monitor, Model 9528.
| Device ID | K103764 |
| 510k Number | K103764 |
| Device Name: | REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529 AND REVEAL DX INSERTABLE CARDIAC MONITOR, MODEL 9528 |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | MEDTRONIC INC. 8200 CORAL SEA ST NE Mounds View, MN 55112 |
| Contact | Yukiko Corson |
| Correspondent | Yukiko Corson MEDTRONIC INC. 8200 CORAL SEA ST NE 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 | 2010-12-23 |
| Decision Date | 2011-05-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169494893 | K103764 | 000 |
| 00643169472211 | K103764 | 000 |
| 00643169472143 | K103764 | 000 |
| 00643169093881 | K103764 | 000 |