FDA 510(k) Application Details - K980505

Device Classification Name	Audiometer   More FDA Info for this Device
510(K) Number	K980505
Device Name	Audiometer
Applicant	HORTMANN AG P.O. BOX 1119 DRIPPING SPRINGS, TX 78620 US Other 510(k) Applications for this Company
Contact	BRADFORD MELANCON 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	02/09/1998
Decision Date	04/07/1998
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