FDA 510(k) Application Details - K183325

Device Classification Name	Neurological Stereotaxic Instrument   More FDA Info for this Device
510(K) Number	K183325
Device Name	Neurological Stereotaxic Instrument
Applicant	Synaptive Medical Inc. 555 Richmond Street West, Suite 800 Toronto M5V 3B1 CA Other 510(k) Applications for this Company
Contact	Maham Ansari 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	11/30/2018
Decision Date	07/14/2019
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