FDA 510(k) Application Details - K980377

Device Classification Name	Calibrator, Hearing Aid / Earphone And Analysis Systems   More FDA Info for this Device
510(K) Number	K980377
Device Name	Calibrator, Hearing Aid / Earphone And Analysis Systems
Applicant	FRYE ELECTRONICS, INC. 9826 S.W. TIGARD ST. TIGARD, OR 97223 US Other 510(k) Applications for this Company
Contact	GEORGE J FRYE Other 510(k) Applications for this Contact
Regulation Number	874.3310   More FDA Info for this Regulation Number
Classification Product Code	ETW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/02/1998
Decision Date	03/18/1998
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