Submission Details
| 510(k) Number | K171514 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 24, 2017 |
| Decision Date | June 29, 2017 |
| Days to Decision | 36 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set
Jun 2017
Decision
36d
Days
Class 2
Risk
About This 510(k) Submission
K171514 is an FDA 510(k) clearance for the BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set, 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 June 29, 2017, 36 days after receiving the submission on May 24, 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
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