TM-5 Intracranial Pressure Monitor
FDA 510(k) K802149 · Nicolet Biomedical Instruments
510(k) numberK802149
Submission
- Device name
- TM-5 Intracranial Pressure Monitor
- Applicant
- Nicolet Biomedical Instruments
Mchenry, IL, US - Received
- September 8, 1980
- Decision date
- November 12, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was TM-5 Intracranial Pressure Monitor cleared by the FDA?
TM-5 Intracranial Pressure Monitor (K802149) received a 510(k) decision of Substantially Equivalent on November 12, 1980, 65 days after the submission was received.
What is the product code of K802149?
The FDA product code is GWM – Device, Monitoring, Intracranial Pressure, a Class II (moderate risk) device regulated under 21 CFR 882.1620.