FDA 510(k) Application Details - K181195

Device Classification Name	More FDA Info for this Device
510(K) Number	K181195
Device Name	ClearPoint System
Applicant	MRI Interventions, Inc. 5 Musick Irvine, CA 92618 US Other 510(k) Applications for this Company
Contact	Pete Piferi Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	ORR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/04/2018
Decision Date	11/02/2018
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