FDA 510(k) Application Details - K200630

Device Classification Name	Device, Monitoring, Intracranial Pressure   More FDA Info for this Device
510(K) Number	K200630
Device Name	Device, Monitoring, Intracranial Pressure
Applicant	Medtronic, Inc. 5290 California Ave Irvine, CA 92617 US Other 510(k) Applications for this Company
Contact	Jen Correa Other 510(k) Applications for this Contact
Regulation Number	882.1620   More FDA Info for this Regulation Number
Classification Product Code	GWM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/10/2020
Decision Date	04/09/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review