510(k) K031084

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

K031084 is an FDA 510(k) premarket notification submitted by Medical Measurement Systems B.V. for the device "SOLAR GI SYSTEM". The FDA issued a decision of Substantially Equivalent on March 19, 2004. The device falls under product code FFX (System, Gastrointestinal Motility (Electrical)), a Class II device regulated under 21 CFR 876.1725. Medical Measurement Systems B.V. has at least 6 other 510(k) clearances on record.