510(k) K013428

MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM by Ohio Medical Instrument Co., Inc. — Product Code HAW

K013428 is an FDA 510(k) premarket notification submitted by Ohio Medical Instrument Co., Inc. for the device "MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM". The FDA issued a decision of Substantially Equivalent on April 4, 2002. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Ohio Medical Instrument Co., Inc. has at least 10 other 510(k) clearances on record.