510(k) K212954
K212954 is an FDA 510(k) premarket notification submitted by G-Tech Medical for the device "G-Tech Wireless Patch System (WPS)". The FDA issued a decision of Substantially Equivalent on January 10, 2022. The device falls under product code MYE (System, Electrogastrography (Egg)), a Class II device regulated under 21 CFR 876.1735.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 10, 2022
- Date Received
- September 16, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Electrogastrography (Egg)
- Device Class
- Class II
- Regulation Number
- 876.1735
- Review Panel
- GU
- Submission Type