510(k) K223398
K223398 is an FDA 510(k) premarket notification submitted by Alimetry , Ltd. for the device "Gastric Alimetry System". The FDA issued a decision of Substantially Equivalent on April 27, 2023. 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
- April 27, 2023
- Date Received
- November 8, 2022
- 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