Intracranial Pressure Monitoring Device
FDA 510(k) K822864 · Medex, Inc.
510(k) numberK822864
Submission
- Device name
- Intracranial Pressure Monitoring Device
- Applicant
- Medex, Inc.
Walker, MI, US - Received
- September 27, 1982
- Decision date
- November 16, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Intracranial Pressure Monitoring Device cleared by the FDA?
Intracranial Pressure Monitoring Device (K822864) received a 510(k) decision of Substantially Equivalent on November 16, 1982, 50 days after the submission was received.
What is the product code of K822864?
The FDA product code is GWM – Device, Monitoring, Intracranial Pressure, a Class II (moderate risk) device regulated under 21 CFR 882.1620.