The following data is part of a premarket notification filed by Medtronic. Inc. with the FDA for Reveal Linq Insertable Cardiac Monitor.
| Device ID | K212008 |
| 510k Number | K212008 |
| Device Name: | Reveal LINQ Insertable Cardiac Monitor |
| Classification | Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection) |
| Applicant | Medtronic. Inc. 8200 Coral Sea Street NE Mounds View, MN 55112 |
| Contact | Andrea Artman |
| Correspondent | Andrea Artman Medtronic. Inc. 8200 Coral Sea Street NE Mounds View, MN 55112 |
| Product Code | MXD |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-28 |
| Decision Date | 2021-07-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000562632 | K212008 | 000 |
| 00763000562625 | K212008 | 000 |