K223398 is an FDA 510(k) clearance for the Gastric Alimetry System. This device is classified as a System, Electrogastrography (egg) (Class II - Special Controls, product code MYE).
Submitted by Alimetry , Ltd. (Grafton, NZ). The FDA issued a Cleared decision on April 27, 2023, 170 days after receiving the submission on November 8, 2022.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1735.
| 510(k) Number | K223398 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 2022 |
| Decision Date | April 27, 2023 |
| Days to Decision | 170 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | MYE - System, Electrogastrography (egg) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1735 |