The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Linq Ii Insertable Cardiac Monitor, Linq Mobile Manager, Device Command Library, Instrument Command Library, Linq Tool Kit.
| Device ID | K200795 |
| 510k Number | K200795 |
| Device Name: | LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool Kit |
| Classification | Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection) |
| Applicant | Medtronic, Inc. 8200 Coral Sea Street NE Mounds View, MN 55112 |
| Contact | Eric Kalmes |
| Correspondent | Eric Kalmes Medtronic, Inc. 8200 Coral Sea Street NE Mounds View, MN 55112 |
| Product Code | MXD |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-26 |
| Decision Date | 2020-07-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000162191 | K200795 | 000 |
| 00763000060374 | K200795 | 000 |