FDA 510(k) Application Details - K981142

Device Classification Name	Audiometer   More FDA Info for this Device
510(K) Number	K981142
Device Name	Audiometer
Applicant	BERNAFON-MAICO, INC. 9675 WEST 76TH ST. EDEN PRAIRIE, MN 55344 US Other 510(k) Applications for this Company
Contact	SCOTT SAVRE Other 510(k) Applications for this Contact
Regulation Number	874.1050   More FDA Info for this Regulation Number
Classification Product Code	EWO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/30/1998
Decision Date	04/22/1998
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