FDA 510(k) Application Details - K061645

Device Classification Name	Stimulator, Electrical, Evoked Response   More FDA Info for this Device
510(K) Number	K061645
Device Name	Stimulator, Electrical, Evoked Response
Applicant	TONICA ELEKTRONIK A/S LUCERNEMARKEN 15 FARUM 3520 DK Other 510(k) Applications for this Company
Contact	LISE TERKELSEN Other 510(k) Applications for this Contact
Regulation Number	882.1870   More FDA Info for this Regulation Number
Classification Product Code	GWF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/12/2006
Decision Date	10/31/2006
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