K201865 is an FDA 510(k) clearance for the Biomonitor III, Biomonitor IIIm. 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 December 8, 2020, 155 days after receiving the submission on July 6, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K201865 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 2020 |
| Decision Date | December 08, 2020 |
| Days to Decision | 155 days |
| Submission Type | Traditional |
| 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 |