FDA 510(k) Application Details - K163439

Device Classification Name	Neurological Stereotaxic Instrument   More FDA Info for this Device
510(K) Number	K163439
Device Name	Neurological Stereotaxic Instrument
Applicant	ClaroNav Inc. 1140 Sheppard Avenue West - Unit 10 Toronto M3K 2A2 CA Other 510(k) Applications for this Company
Contact	Ahmad Kolahi Other 510(k) Applications for this Contact
Regulation Number	882.4560   More FDA Info for this Regulation Number
Classification Product Code	HAW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/08/2016
Decision Date	09/01/2017
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