510(k) K213924
- Device
- Gastric Alimetry System
- Applicant
- Alimetry Ltd.
- 510(k) number
- K213924
- Product code
- MYE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-06-03
- Date received
- 2021-12-15
- Regulation
- 876.1735
- Classification name
- System, Electrogastrography (egg)
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Yaara Yarmut
- Address
- 70 Symonds St. Grafton NZ 1010 1010
FDA Registration Numbers#
- 3030686085
- 2954356
- 3023209868
Source Documents#
Other 510(k) Records For Product Code MYE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252504 | Gastric Alimetry | Alimetry , Ltd. | 2025-12-05 |
| K240946 | Gastric Alimetry | Alimetry , Ltd. | 2024-07-03 |
| K232925 | Gastric Alimetry System | Alimetry , Ltd. | 2023-11-17 |
| K223398 | Gastric Alimetry System | Alimetry , Ltd. | 2023-04-27 |
| K212954 | G-Tech Wireless Patch System (WPS) | G-Tech Medical | 2022-01-10 |
| K014269 | POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL 9043S0151; POLYGRAF ID, MODEL 9043G0102 | Medtronic Functional Diagnostics A/S | 2002-11-21 |
| DEN990005 | THE 3PM EGG MACHINE | 3pm Co., Inc. | 1999-08-20 |
Legacy Summary#
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FDA Review#
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