510(k) K121014

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

K121014 is an FDA 510(k) premarket notification submitted by Medical Measurement Systems B.V. for the device "SOLAR GI". The FDA issued a decision of Substantially Equivalent on August 1, 2012. 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.