FDA 510(k) Application Details - K982441

Device Classification Name	Audiometer   More FDA Info for this Device
510(K) Number	K982441
Device Name	Audiometer
Applicant	BENSON MEDICAL INSTRUMENTS CO. 2344 NICOLLET AVE. SOUTH, #150 MINNEAPOLIS, MN 55404 US Other 510(k) Applications for this Company
Contact	DAVID P MAYOU 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	07/14/1998
Decision Date	10/09/1998
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