FDA 510(k) Application Details - K070312

Device Classification Name	Tester, Auditory Impedance   More FDA Info for this Device
510(K) Number	K070312
Device Name	Tester, Auditory Impedance
Applicant	INNOVIA MEDICAL, LLC 13 RED FOX LANE LITTLETON, CO 80127 US Other 510(k) Applications for this Company
Contact	Kevin Walls 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	02/01/2007
Decision Date	03/02/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review