FDA 510(k) Application Details - K171506

Device Classification Name	Audiometer   More FDA Info for this Device
510(K) Number	K171506
Device Name	Audiometer
Applicant	Maico Diagnostics GmbH Sickingenstr. 70-71 Berlin 10553 DE Other 510(k) Applications for this Company
Contact	Amy Yanta 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	05/23/2017
Decision Date	08/29/2017
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