FDA 510(k) Application Details - K982566

Device Classification Name	Audiometer   More FDA Info for this Device
510(K) Number	K982566
Device Name	Audiometer
Applicant	BAR - ADVANCED CONTROL SYSTEMS LTD. P.O. BOX 454 GINOT SHOMRON 44853 IL Other 510(k) Applications for this Company
Contact	AHAVA STEIN 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	07/23/1998
Decision Date	10/21/1998
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