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510(k) K031084

SOLAR GI SYSTEM by Medical Measurement Systems B.V. — Product Code FFX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 2004
Date Received
April 4, 2003
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.

  • K121014 — SOLAR GI (August 1, 2012)
  • K071094 — MODIFICATION TO SOLAR GI (August 13, 2007)
  • K060166 — OHMEGA (April 21, 2006)
  • K052338 — SOLAR GI (December 15, 2005)
  • K050993 — MMS VIDEO OPTION (May 26, 2005)
  • K031930 — HIGH SPEED EMG MODULE (March 3, 2004)

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  • K231861 — EndoflipTM 300 System (July 21, 2023)
  • K223705 — EndoflipTM 300 (April 14, 2023)
  • 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)