FDA 510(k) Application Details - K973377

Device Classification Name	Audiometer   More FDA Info for this Device
510(K) Number	K973377
Device Name	Audiometer
Applicant	TRUTONE 3113 SOUTH 115TH EAST AVE. TULSA, OK 74146 US Other 510(k) Applications for this Company
Contact	ZIAD SHWIYAT 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	09/08/1997
Decision Date	03/10/1998
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