Home / 510(k) Clearances / DEN990005

510(k) DEN990005

THE 3PM EGG MACHINE by 3pm Co., Inc. — Product Code MYE

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
August 20, 1999
Date Received
July 12, 1999
Clearance Type
Post-NSE
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 for product code MYE

  • K252504 — Gastric Alimetry (December 5, 2025)
  • 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)