510(k) K093304

PROTEKTOR 32 by Natus Medical, Inc. — Product Code GWF

K093304 is an FDA 510(k) premarket notification submitted by Natus Medical, Inc. for the device "PROTEKTOR 32". The FDA issued a decision of Substantially Equivalent on August 11, 2010. The device falls under product code GWF (Stimulator, Electrical, Evoked Response), a Class II device regulated under 21 CFR 882.1870. Natus Medical, Inc. has at least 10 other 510(k) clearances on record.