FDA 510(k) Application Details - K962012

Device Classification Name	Audiometer   More FDA Info for this Device
510(K) Number	K962012
Device Name	Audiometer
Applicant	ETHICAL HEARING INSTRUMENTS 90 FLEET ST. PORTSMOUTH, NH 03801 US Other 510(k) Applications for this Company
Contact	DAVID J DELAGE 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	05/23/1996
Decision Date	08/21/1996
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