510(k) K130346

SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSION by Natus Neurology Incorporated — Product Code GWF

K130346 is an FDA 510(k) premarket notification submitted by Natus Neurology Incorporated for the device "SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSION". The FDA issued a decision of Substantially Equivalent on May 2, 2013. The device falls under product code GWF (Stimulator, Electrical, Evoked Response), a Class II device regulated under 21 CFR 882.1870. Natus Neurology Incorporated has at least 4 other 510(k) clearances on record.