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510(k) K060166

OHMEGA by Medical Measurement Systems B.V. — Product Code FFX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 2006
Date Received
January 23, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Gastrointestinal Motility (Electrical)
Device Class
Class II
Regulation Number
876.1725
Review Panel
GU
Submission Type

Other clearances by Medical Measurement Systems B.V.

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  • K071094 — MODIFICATION TO SOLAR GI (August 13, 2007)
  • K052338 — SOLAR GI (December 15, 2005)
  • K050993 — MMS VIDEO OPTION (May 26, 2005)
  • K031084 — SOLAR GI SYSTEM (March 19, 2004)
  • K031930 — HIGH SPEED EMG MODULE (March 3, 2004)

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  • K222000 — Transit-Pellets (January 18, 2023)
  • K201106 — IntraMarX 3D Radiopaque Marker (May 21, 2020)
  • K191087 — IntraMarX Radiopaque Markers (December 18, 2019)
  • K190208 — Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe (October 3, 2019)
  • K181760 — Transit-Pellets (August 8, 2019)
  • K183072 — EndoFLIP System (February 15, 2019)