FDA 510(k) Application Details - K033645

Device Classification Name	Tester, Auditory Impedance   More FDA Info for this Device
510(K) Number	K033645
Device Name	Tester, Auditory Impedance
Applicant	GN OTOMETRICS A/S DYBENDALSVAENGET 2 P.O. BOX 119 TAASTRUP DK-2630 DK Other 510(k) Applications for this Company
Contact	PER PAPE THOMSEN 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	11/20/2003
Decision Date	03/31/2004
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