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510(k) K232925

Gastric Alimetry System by Alimetry , Ltd. — Product Code MYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2023
Date Received
September 19, 2023
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.

  • K252504 — Gastric Alimetry (December 5, 2025)
  • K240946 — Gastric Alimetry (July 3, 2024)
  • K223398 — Gastric Alimetry System (April 27, 2023)
  • K213924 — Gastric Alimetry System (June 3, 2022)

Other clearances for product code MYE

  • K252504 — Gastric Alimetry (December 5, 2025)
  • K240946 — Gastric Alimetry (July 3, 2024)
  • 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)