FDA 510(k) Application Details - DEN130019

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN130019
Device Name	ZANZA-CLICK
Applicant	TECNIMED S.R.L. 110 E. GRANADA BLVD SUITE 209 ORMOND BEACH, FL 32176 US Other 510(k) Applications for this Company
Contact	Claude Berthoin Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OSG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/28/2013
Decision Date	11/07/2014
Decision	DENG -
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review