FDA 510(k) Application Details - K983049

Device Classification Name	Tester, Auditory Impedance   More FDA Info for this Device
510(K) Number	K983049
Device Name	Tester, Auditory Impedance
Applicant	AMERICAN ELECTROMEDICS CORP. P.O. BOX 9169 CHICO, CA 95927 US Other 510(k) Applications for this Company
Contact	FRANK FERGUSON Other 510(k) Applications for this Contact
Regulation Number	874.1090   More FDA Info for this Regulation Number
Classification Product Code	ETY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/01/1998
Decision Date	11/18/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review