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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Gastrointestinal Motility (Electrical)
510(k) Number K052338
Device Name SOLAR GI
Applicant
Medical Measurement Systems B.V.
Colosseum 25
Enschede Overijssel,  NL 7521 PV
Applicant Contact KARIN OGINK-SOMHORST
Correspondent
Medical Measurement Systems B.V.
Colosseum 25
Enschede Overijssel,  NL 7521 PV
Correspondent Contact KARIN OGINK-SOMHORST
Regulation Number876.1725
Classification Product Code
FFX  
Date Received08/26/2005
Decision Date 12/15/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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