FDA 510(k) Application Details - K171265

Device Classification Name	Tympanometer   More FDA Info for this Device
510(K) Number	K171265
Device Name	Tympanometer
Applicant	Amplivox Ltd 6 Oasis Park Eynsham OX29 4tp GB Other 510(k) Applications for this Company
Contact	Chris Roerig Other 510(k) Applications for this Contact
Regulation Number	874.1090   More FDA Info for this Regulation Number
Classification Product Code	NAS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/01/2017
Decision Date	07/28/2017
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