Becker External Drainage and Monitoring System
FDA 510(k) K200456 · Medtronic, Inc.
510(k) numberK200456
Submission
- Device name
- Becker External Drainage and Monitoring System
- Applicant
- Medtronic, Inc.
Goleta, CA, US - Received
- February 25, 2020
- Decision date
- March 26, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Becker External Drainage and Monitoring System cleared by the FDA?
Becker External Drainage and Monitoring System (K200456) received a 510(k) decision of Substantially Equivalent on March 26, 2020, 30 days after the submission was received.
What is the product code of K200456?
The FDA product code is GWM – Device, Monitoring, Intracranial Pressure, a Class II (moderate risk) device regulated under 21 CFR 882.1620.