The following data is part of a premarket notification filed by Alimetry Ltd. with the FDA for Gastric Alimetry System.
| Device ID | K213924 |
| 510k Number | K213924 |
| Device Name: | Gastric Alimetry System |
| Classification | System, Electrogastrography (egg) |
| Applicant | Alimetry Ltd. 70 Symonds Street Grafton, NZ 1010 |
| Contact | Yaara Yarmut |
| Correspondent | Janice Hogan Hogan Lovells US LLP 1735 Market Street, Floor 23 Philadelphia, PA 19115 |
| Product Code | MYE |
| CFR Regulation Number | 876.1735 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-15 |
| Decision Date | 2022-06-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09421906857030 | K213924 | 000 |
| 09421906857023 | K213924 | 000 |
| 09421906857009 | K213924 | 000 |
| 09421906857122 | K213924 | 000 |