510(k) K161566

DMS Disposable Subdermal Needle Electrodes by Daehan Medical Systems Co., Ltd. — Product Code GXZ

K161566 is an FDA 510(k) premarket notification submitted by Daehan Medical Systems Co., Ltd. for the device "DMS Disposable Subdermal Needle Electrodes". The FDA issued a decision of Substantially Equivalent on December 21, 2016. The device falls under product code GXZ (Electrode, Needle), a Class II device regulated under 21 CFR 882.1350. Daehan Medical Systems Co., Ltd. has at least 2 other 510(k) clearances on record.