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510(k) K212954

G-Tech Wireless Patch System (WPS) by G-Tech Medical — Product Code MYE

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

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  • K232925 — Gastric Alimetry System (November 17, 2023)
  • K223398 — Gastric Alimetry System (April 27, 2023)
  • K213924 — Gastric Alimetry System (June 3, 2022)
  • K014269 — POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL 9043S0151; POLYGRAF (November 21, 2002)
  • DEN990005 — THE 3PM EGG MACHINE (August 20, 1999)