510(k) K942008

INTERACOUSTICS AUTOMATIC IMPEDANCE AUDIOMETER by Precision Acoustics Ind., Inc. — Product Code ETY

K942008 is an FDA 510(k) premarket notification submitted by Precision Acoustics Ind., Inc. for the device "INTERACOUSTICS AUTOMATIC IMPEDANCE AUDIOMETER". The FDA issued a decision of Substantially Equivalent on August 24, 1994. The device falls under product code ETY (Tester, Auditory Impedance), a Class II device regulated under 21 CFR 874.1090. Precision Acoustics Ind., Inc. has at least 8 other 510(k) clearances on record.