FDA 510(k) Application Details - K242034

Device Classification Name	More FDA Info for this Device
510(K) Number	K242034
Device Name	Duet External Drainage and Monitoring System (EDMS)
Applicant	Medtronic Neurosurgery 4620 N Beach Street Fort Worth, TX 76137 US Other 510(k) Applications for this Company
Contact	Foram Shukla Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PCB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/11/2024
Decision Date	10/24/2024
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