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510(k) K052338

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2005
Date Received
August 26, 2005
Clearance Type
Special
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)
  • 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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  • K191087 — IntraMarX Radiopaque Markers (December 18, 2019)
  • K190208 — Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe (October 3, 2019)
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