FDA 510(k) Application Details - K211147

Device Classification Name	Stimulator, Auditory, Evoked Response   More FDA Info for this Device
510(K) Number	K211147
Device Name	Stimulator, Auditory, Evoked Response
Applicant	Path Medical GmbH Landsberger Strasse 65 Germering 82110 DE Other 510(k) Applications for this Company
Contact	Ing. Johann Oswald Other 510(k) Applications for this Contact
Regulation Number	882.1900   More FDA Info for this Regulation Number
Classification Product Code	GWJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/19/2021
Decision Date	10/14/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review