FDA 510(k) Application Details - K182889

Device Classification Name	More FDA Info for this Device
510(K) Number	K182889
Device Name	KLS Martin Individual Patient Solutions (IPS) Planning System
Applicant	KLS-Martin L.P. 11201 Saint Johns Industrial Parkway S Jacksonville, FL 32246 US Other 510(k) Applications for this Company
Contact	Jennifer Damato Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PPT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/15/2018
Decision Date	07/26/2019
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