510(k) K942008

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 1994
Date Received
April 25, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tester, Auditory Impedance
Device Class
Class II
Regulation Number
874.1090
Review Panel
EN
Submission Type