The following data is part of a premarket notification filed by Medtronic,inc. with the FDA for Reveal Linq Insertable Cardiac Monitor.
| Device ID | K163460 |
| 510k Number | K163460 |
| Device Name: | Reveal LINQ Insertable Cardiac Monitor |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | MEDTRONIC,INC. 8200 CORAL SEA ST NE Mounds View, MN 55112 |
| Contact | Laura Danielson |
| Correspondent | Laura Danielson 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 | 2016-12-09 |
| Decision Date | 2017-02-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169855519 | K163460 | 000 |
| 00763000060428 | K163460 | 000 |