510(k) K971747

AMPLAID 460 by Amplifon S.P.A. — Product Code EWO

K971747 is an FDA 510(k) premarket notification submitted by Amplifon S.P.A. for the device "AMPLAID 460". The FDA issued a decision of Substantially Equivalent on August 5, 1997. The device falls under product code EWO (Audiometer), a Class II device regulated under 21 CFR 874.1050. Amplifon S.P.A. has at least 7 other 510(k) clearances on record.