K170628 is an FDA 510(k) clearance for the BioMonitor 2-AF, BioMonitor 2-S. This device is classified as a Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection) (Class II - Special Controls, product code MXD).
Submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on March 31, 2017, 29 days after receiving the submission on March 2, 2017.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K170628 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 02, 2017 |
| Decision Date | March 31, 2017 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MXD — Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1025 |