510(k) K983397

STEALTHSTATION TREATMENT GUIDANCE PLAFFORM by Surgical Navigation Technologies, Inc. — Product Code HAW

K983397 is an FDA 510(k) premarket notification submitted by Surgical Navigation Technologies, Inc. for the device "STEALTHSTATION TREATMENT GUIDANCE PLAFFORM". The FDA issued a decision of Substantially Equivalent on December 4, 1998. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Surgical Navigation Technologies, Inc. has at least 10 other 510(k) clearances on record.