FDA 510(k) Application Details - K971859

Device Classification Name	Tester, Auditory Impedance   More FDA Info for this Device
510(K) Number	K971859
Device Name	Tester, Auditory Impedance
Applicant	MDI INSTRUMENTS, INC. 200 UNICORE PARK DR. WOBURN, MA 01801 US Other 510(k) Applications for this Company
Contact	SANDRA KIMBALL Other 510(k) Applications for this Contact
Regulation Number	874.1090   More FDA Info for this Regulation Number
Classification Product Code	ETY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/20/1997
Decision Date	08/18/1997
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