FDA 510(k) Application Details - K022728

Device Classification Name	Tester, Auditory Impedance   More FDA Info for this Device
510(K) Number	K022728
Device Name	Tester, Auditory Impedance
Applicant	INTERACOUSTICS A/S, ASSENS 9675 WEST 76TH ST. EDEN PRAIRIE, MN 55344 US Other 510(k) Applications for this Company
Contact	DANIEL EGGAN 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	08/16/2002
Decision Date	10/11/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review