510(k) K183123

microTargeting Guideline 4000 5.0 System by FHC, Inc. — Product Code GZL

K183123 is an FDA 510(k) premarket notification submitted by FHC, Inc. for the device "microTargeting Guideline 4000 5.0 System". The FDA issued a decision of Substantially Equivalent on December 20, 2018. The device falls under product code GZL (Electrode, Depth), a Class II device regulated under 21 CFR 882.1330. FHC, Inc. has at least 10 other 510(k) clearances on record.