510(k) K212954
- Device
- G-Tech Wireless Patch System (WPS)
- Applicant
- G-Tech Medical
- 510(k) number
- K212954
- Product code
- MYE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-01-10
- Date received
- 2021-09-16
- 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
- Steve Axelrod
- Address
- 2495 Hospital Dr., Suite 300 Mountain View CA US 94040 94040
FDA Registration Numbers#
- 2954356
- 3023209868
- 3030686085
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 |
| K213924 | Gastric Alimetry System | Alimetry , Ltd. | 2022-06-03 |
| 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 |