510(k) K031930

HIGH SPEED EMG MODULE by Medical Measurement Systems B.V. — Product Code GWF

K031930 is an FDA 510(k) premarket notification submitted by Medical Measurement Systems B.V. for the device "HIGH SPEED EMG MODULE". The FDA issued a decision of Substantially Equivalent on March 3, 2004. The device falls under product code GWF (Stimulator, Electrical, Evoked Response), a Class II device regulated under 21 CFR 882.1870. Medical Measurement Systems B.V. has at least 6 other 510(k) clearances on record.