FDA 510(k) Application Details - K140680

Device Classification Name	Electrode, Depth   More FDA Info for this Device
510(K) Number	K140680
Device Name	Electrode, Depth
Applicant	ALPINE BIOMED APS TONSBAKKEN 16 - 18 SKOVLUNDE DK-2740 DK Other 510(k) Applications for this Company
Contact	Seamus O'Connor Other 510(k) Applications for this Contact
Regulation Number	882.1330   More FDA Info for this Regulation Number
Classification Product Code	GZL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/18/2014
Decision Date	12/12/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review