FDA 510(k) Application Details - K964426

Device Classification Name	Audiometer   More FDA Info for this Device
510(K) Number	K964426
Device Name	Audiometer
Applicant	INTELLIGENT HEARING SYSTEMS 10689 N. KENDALL DR. SUITE 315 NORTH MIAMI, FL 33176 US Other 510(k) Applications for this Company
Contact	EDWARD MISKIEL 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	11/05/1996
Decision Date	02/03/1997
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