510(k) K972959

AMPLAID MK22 by Amplifon S.P.A. — Product Code GWF

K972959 is an FDA 510(k) premarket notification submitted by Amplifon S.P.A. for the device "AMPLAID MK22". The FDA issued a decision of Substantially Equivalent on February 6, 1998. The device falls under product code GWF (Stimulator, Electrical, Evoked Response), a Class II device regulated under 21 CFR 882.1870. Amplifon S.P.A. has at least 7 other 510(k) clearances on record.