FDA 510(k) Application Details - K050496

Device Classification Name	Calibrator, Hearing Aid / Earphone And Analysis Systems   More FDA Info for this Device
510(K) Number	K050496
Device Name	Calibrator, Hearing Aid / Earphone And Analysis Systems
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	874.3310   More FDA Info for this Regulation Number
Classification Product Code	ETW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/28/2005
Decision Date	04/29/2005
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