Carnation Ambulatory Monitor (CAM) — Bardy Diagnostics, Inc. (510(k) K210036)
Carnation Ambulatory Monitor (CAM) — Bardy Diagnostics, Inc. (510(k) K210036) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Carnation Ambulatory Monitor (CAM); Applicant: Bardy Diagnostics, Inc.; Clearance track: 510(k).
| Device name | Carnation Ambulatory Monitor (CAM) |
|---|---|
| Applicant | Bardy Diagnostics, Inc. |
| Clearance track | 510(k) |
| Submission number | K210036 |
| Decision | Substantially Equivalent |
| Decision date | 2021-02-05 |
| Date received | 2021-01-06 |
| Product code | DSH |
| Device class | 2 |
| Medical specialty | Cardiovascular |
| Applicant location | WA, US |
| Source | openFDA device |
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