510(k) K252504
K252504 is an FDA 510(k) premarket notification submitted by Alimetry , Ltd. for the device "Gastric Alimetry". The FDA issued a decision of Substantially Equivalent on December 5, 2025. The device falls under product code MYE (System, Electrogastrography (Egg)), a Class II device regulated under 21 CFR 876.1735. Alimetry , Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 5, 2025
- Date Received
- August 8, 2025
- 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