BIOMONITOR IV — Biotronik, Inc. (510(k) K230375)
BIOMONITOR IV — Biotronik, Inc. (510(k) K230375) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: BIOMONITOR IV; Applicant: Biotronik, Inc.; Clearance track: 510(k).
| Device name | BIOMONITOR IV |
|---|---|
| Applicant | Biotronik, Inc. |
| Clearance track | 510(k) |
| Submission number | K230375 |
| Decision | Substantially Equivalent |
| Decision date | 2023-05-19 |
| Date received | 2023-02-13 |
| Product code | MXD |
| Device class | 2 |
| Medical specialty | Cardiovascular |
| Applicant location | OR, US |
| Source | openFDA device |
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