510(k) K201678

iCE-SG Subcutaneous Electrode Arrays by Ice Neurosystems, Inc. — Product Code GZL

K201678 is an FDA 510(k) premarket notification submitted by Ice Neurosystems, Inc. for the device "iCE-SG Subcutaneous Electrode Arrays". The FDA issued a decision of Substantially Equivalent on March 8, 2021. The device falls under product code GZL (Electrode, Depth), a Class II device regulated under 21 CFR 882.1330. Ice Neurosystems, Inc. has at least 2 other 510(k) clearances on record.