Submission Details
| 510(k) Number | K221856 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 27, 2022 |
| Decision Date | July 27, 2022 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
BIOMONITOR IIIm, BIOMONITOR III
Jul 2022
Decision
30d
Days
Class 2
Risk
About This 510(k) Submission
K221856 is an FDA 510(k) clearance for the BIOMONITOR IIIm, BIOMONITOR III, 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 July 27, 2022, 30 days after receiving the submission on June 27, 2022. 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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