The following data is part of a premarket notification filed by Biotronik, Inc. with the FDA for Biomonitor 2-af, Biomonitor 2-s, Fit - Fast Insert Tool 1 + 2, Set.
| Device ID | K171514 |
| 510k Number | K171514 |
| Device Name: | BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set |
| Classification | Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection) |
| Applicant | BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035 |
| Contact | Jon Brumbaugh |
| Correspondent | Jon Brumbaugh BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035 |
| Product Code | MXD |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-24 |
| Decision Date | 2017-06-29 |
| Summary: | summary |