XChange Device, XChange System — Pneuma Therapeutics, Inc. (510(k) K210112)
XChange Device, XChange System — Pneuma Therapeutics, Inc. (510(k) K210112) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: XChange Device, XChange System; Applicant: Pneuma Therapeutics, Inc.; Clearance track: 510(k).
| Device name | XChange Device, XChange System |
|---|---|
| Applicant | Pneuma Therapeutics, Inc. |
| Clearance track | 510(k) |
| Submission number | K210112 |
| Decision | Substantially Equivalent |
| Decision date | 2023-01-30 |
| Date received | 2021-01-19 |
| Product code | CCK |
| Device class | 2 |
| Medical specialty | Anesthesiology |
| Applicant location | AZ, US |
| Source | openFDA device |
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