510(k) K012306

AUDIOSCAN VERIFIT, MODEL VF-1 by Etymonic Design, Inc. — Product Code ETW

K012306 is an FDA 510(k) premarket notification submitted by Etymonic Design, Inc. for the device "AUDIOSCAN VERIFIT, MODEL VF-1". The FDA issued a decision of Substantially Equivalent on September 21, 2001. The device falls under product code ETW (Calibrator, Hearing Aid / Earphone And Analysis Systems), a Class II device regulated under 21 CFR 874.3310. Etymonic Design, Inc. has at least 1 other 510(k) clearance on record.