510(k) K070312

EARCHECK ACOUSTIC REFLECTOMETER by Innovia Medical, LLC — Product Code ETY

K070312 is an FDA 510(k) premarket notification submitted by Innovia Medical, LLC for the device "EARCHECK ACOUSTIC REFLECTOMETER". The FDA issued a decision of Substantially Equivalent on March 2, 2007. The device falls under product code ETY (Tester, Auditory Impedance), a Class II device regulated under 21 CFR 874.1090.