FDA 510(k) Application Details - K982249

Device Classification Name	Audiometer   More FDA Info for this Device
510(K) Number	K982249
Device Name	Audiometer
Applicant	IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE) 4814 EAST SECOND ST. BENICIA, CA 94510 US Other 510(k) Applications for this Company
Contact	DONNA WARD 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	06/26/1998
Decision Date	08/07/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review