510(k) K200456

Becker External Drainage and Monitoring System by Medtronic, Inc. — Product Code GWM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 2020
Date Received
February 25, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Monitoring, Intracranial Pressure
Device Class
Class II
Regulation Number
882.1620
Review Panel
NE
Submission Type