510(k) K033645

OTOFLEX 100 TYE 1012 by Gn Otometrics A/S — Product Code ETY

K033645 is an FDA 510(k) premarket notification submitted by Gn Otometrics A/S for the device "OTOFLEX 100 TYE 1012". The FDA issued a decision of Substantially Equivalent on March 31, 2004. The device falls under product code ETY (Tester, Auditory Impedance), a Class II device regulated under 21 CFR 874.1090. Gn Otometrics A/S has at least 10 other 510(k) clearances on record.