510(k) K140680

LEADPOINT FOCUS WORKSTSTION, LEADPOINT FOCUS NOTEBOOK SYSTEM by Alpine Biomed Aps — Product Code GZL

K140680 is an FDA 510(k) premarket notification submitted by Alpine Biomed Aps for the device "LEADPOINT FOCUS WORKSTSTION, LEADPOINT FOCUS NOTEBOOK SYSTEM". The FDA issued a decision of Substantially Equivalent on December 12, 2014. The device falls under product code GZL (Electrode, Depth), a Class II device regulated under 21 CFR 882.1330.