Intracranial Pressure Monitoring
FDA 510(k) K790920 · Codman & Shurtleff, Inc.
510(k) numberK790920
Submission
- Device name
- Intracranial Pressure Monitoring
- Applicant
- Codman & Shurtleff, Inc.
Walker, MI, US - Received
- May 9, 1979
- Decision date
- August 3, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Intracranial Pressure Monitoring cleared by the FDA?
Intracranial Pressure Monitoring (K790920) received a 510(k) decision of Substantially Equivalent on August 3, 1979, 86 days after the submission was received.
What is the product code of K790920?
The FDA product code is GWM – Device, Monitoring, Intracranial Pressure, a Class II (moderate risk) device regulated under 21 CFR 882.1620.