Submission Details
| 510(k) Number | K170628 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Special
BioMonitor 2-AF, BioMonitor 2-S
Mar 2017
Decision
29d
Days
Class 2
Risk
About This 510(k) Submission
K170628 is an FDA 510(k) clearance for the BioMonitor 2-AF, BioMonitor 2-S, 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 review panel. Regulated under 21 CFR 870.1025.
Device Classification
| Product Code | MXD — Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1025 |
Manufacturer
Similar Devices — MXD Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection)
All 31
K253516 · Abbott Medical
· Dec 2025
K251221 · Abbott
· Sep 2025
K252593 · Boston Scientific Corporation
· Sep 2025
K240693 · Medtronic, Inc.
· Mar 2024
K233562 · Medtronic, Inc.
· Dec 2023
K233320 · Medtronic, Inc.
· Oct 2023
More from Biotronik, Inc.
View all
K250706
· LIT · Apr 2025
K242969
· LOX · Oct 2024
K240787
· DQY · Sep 2024
K241711
· LIT · Jul 2024
K230375
· MXD · May 2023