510(k) K982244

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

K982244 is an FDA 510(k) premarket notification submitted by Ohio Medical Instrument Co., Inc. for the device "MAYFIELD ACCISS OPTICAL SYSTEM". The FDA issued a decision of Substantially Equivalent on September 23, 1998. 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.