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510(k) K252504

Gastric Alimetry by Alimetry , Ltd. — Product Code MYE

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

Other clearances by Alimetry , Ltd.

  • K240946 — Gastric Alimetry (July 3, 2024)
  • K232925 — Gastric Alimetry System (November 17, 2023)
  • K223398 — Gastric Alimetry System (April 27, 2023)
  • K213924 — Gastric Alimetry System (June 3, 2022)

Other clearances for product code MYE

  • K240946 — Gastric Alimetry (July 3, 2024)
  • K232925 — Gastric Alimetry System (November 17, 2023)
  • K223398 — Gastric Alimetry System (April 27, 2023)
  • K213924 — Gastric Alimetry System (June 3, 2022)
  • K212954 — G-Tech Wireless Patch System (WPS) (January 10, 2022)
  • K014269 — POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL 9043S0151; POLYGRAF (November 21, 2002)
  • DEN990005 — THE 3PM EGG MACHINE (August 20, 1999)