FDA 510(k) Application Details - K983851

Device Classification Name	Audiometer   More FDA Info for this Device
510(K) Number	K983851
Device Name	Audiometer
Applicant	MADSEN ELECTRONICS, INC. 5600 ROWLAND RD. MINNETONKA, MN 55343 US Other 510(k) Applications for this Company
Contact	TRACY MILLIER 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	10/30/1998
Decision Date	01/28/1999
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