FDA 510(k) Application Details - K180287

Device Classification Name	Audiometer   More FDA Info for this Device
510(K) Number	K180287
Device Name	Audiometer
Applicant	Grason-Stadler Inc. 10395 West 70th Street Eden Prairie, MN 55344 US 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	02/01/2018
Decision Date	05/11/2018
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