510(k) K051746

ELEKTA ESARTE FRAME SYSTEM by Elekta Instrument AB — Product Code HAW

K051746 is an FDA 510(k) premarket notification submitted by Elekta Instrument AB for the device "ELEKTA ESARTE FRAME SYSTEM". The FDA issued a decision of Substantially Equivalent on July 25, 2005. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Elekta Instrument AB has at least 10 other 510(k) clearances on record.