The following data is part of a premarket notification filed by Biotronik, Inc. with the FDA for Biomonitor Iii, Remote Assistant Iii.
| Device ID | K190548 |
| 510k Number | K190548 |
| Device Name: | BIOMONITOR III, Remote Assistant 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-05 |
| Decision Date | 2019-07-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04035479158453 | K190548 | 000 |
| 04035479158330 | K190548 | 000 |