FDA 510(k) Application Details - K122028

Device Classification Name	Calibrator, Hearing Aid / Earphone And Analysis Systems   More FDA Info for this Device
510(K) Number	K122028
Device Name	Calibrator, Hearing Aid / Earphone And Analysis Systems
Applicant	GN OTOMETRICS 8870 RAVELLO CT NAPLES, FL 34114 US Other 510(k) Applications for this Company
Contact	DANIEL KAMM Other 510(k) Applications for this Contact
Regulation Number	874.3310   More FDA Info for this Regulation Number
Classification Product Code	ETW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/10/2012
Decision Date	10/23/2012
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