Transtar Intracranial Pressure Transducer, Model MX950ICP
FDA 510(k) K020780 · Medex, Inc.
510(k) numberK020780
Submission
- Device name
- Transtar Intracranial Pressure Transducer, Model MX950ICP
- Applicant
- Medex, Inc.
Dublin, OH, US - Received
- March 11, 2002
- Decision date
- May 20, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Transtar Intracranial Pressure Transducer, Model MX950ICP cleared by the FDA?
Transtar Intracranial Pressure Transducer, Model MX950ICP (K020780) received a 510(k) decision of Substantially Equivalent on May 20, 2002, 70 days after the submission was received.
What is the product code of K020780?
The FDA product code is GWM – Device, Monitoring, Intracranial Pressure, a Class II (moderate risk) device regulated under 21 CFR 882.1620.