The following data is part of a premarket notification filed by Biotronik, Inc. with the FDA for Biomonitor Iiim, Biomonitor Iii.
| Device ID | K221856 |
| 510k Number | K221856 |
| Device Name: | BIOMONITOR IIIm, BIOMONITOR III |
| 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 | 2022-06-27 |
| Decision Date | 2022-07-27 |