Submission Details
| 510(k) Number | K190548 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 05, 2019 |
| Decision Date | July 05, 2019 |
| Days to Decision | 122 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
BIOMONITOR III, Remote Assistant III
Jul 2019
Decision
122d
Days
Class 2
Risk
About This 510(k) Submission
K190548 is an FDA 510(k) clearance for the BIOMONITOR III, Remote Assistant 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 5, 2019, 122 days after receiving the submission on March 5, 2019. 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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