FDA 510(k) Application Details - K962995

Device Classification Name	Audiometer   More FDA Info for this Device
510(K) Number	K962995
Device Name	Audiometer
Applicant	OTODYNAMICS, LTD. 36 BEACONSFIELD RD., HATFIELD HERTS AL10 8BB AL10 8BB GB Other 510(k) Applications for this Company
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	08/01/1996
Decision Date	01/10/1997
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