Gastric Alimetry is an AI-enabled medical device from Alimetry , Ltd., listed by FDA (510(k), K252504) with a decision date of 2025-12-05. Review panel: Gastroenterology-Urology.
| FDA submission number | K252504 |
|---|---|
| Pathway | 510(k) |
| Company | Alimetry , Ltd. |
| Review panel (specialty) | Gastroenterology-Urology |
| FDA decision date | 2025-12-05 |
| Decision | Substantially Equivalent |
| Product code | MYE |
| Classification | System, Electrogastrography (Egg) |
| Device class | 2 |
| Regulation number | 876.1735 |
| Review time (calendar days) | 119 |
| Applicant country | NZ |
Official FDA database record · FDA AI-enabled device list
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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.