510(k) K141950

HFD100 ROCKER ARM ACCESSORY by Imris, Inc. — Product Code HBL

K141950 is an FDA 510(k) premarket notification submitted by Imris, Inc. for the device "HFD100 ROCKER ARM ACCESSORY". The FDA issued a decision of Substantially Equivalent on September 4, 2014. The device falls under product code HBL (Holder, Head, Neurosurgical (Skull Clamp)), a Class II device regulated under 21 CFR 882.4460. Imris, Inc. has at least 10 other 510(k) clearances on record.