The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Reveal Linq.
| Device ID | K150614 |
| 510k Number | K150614 |
| Device Name: | Reveal LINQ |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | MEDTRONIC INC. 8200 CORAL SEA ST NE Mounds View, MN 55112 |
| Contact | Dianna L. Johannson |
| Correspondent | Dianna L. Johannson 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 | 2015-03-10 |
| Decision Date | 2015-08-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169782730 | K150614 | 000 |
| 00643169617254 | K150614 | 000 |
| 00643169545519 | K150614 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() REVEAL LINQ 98454020 not registered Live/Pending |
Medtronic, Inc. 2024-03-18 |
![]() REVEAL LINQ 85481814 4689006 Live/Registered |
Medtronic, Inc. 2011-11-28 |