FDA 510(k)

TM-5 INTRACRANIAL PRESSURE MONITOR

K-Number: K802149 · 1980-11-12

Decision Date1980-11-12

Product CodeGWM

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

TM-5 INTRACRANIAL PRESSURE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Nicolet Biomedical Instruments. It received FDA 510(k) clearance on 1980-11-12 under 510(k) number K802149. The device is classified under product code GWM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TM-5 INTRACRANIAL PRESSURE MONITOR?

TM-5 INTRACRANIAL PRESSURE MONITOR is a medical device that received FDA 510(k) clearance on 1980-11-12. The listed applicant is Nicolet Biomedical Instruments. The 510(k) number is K802149.

When did TM-5 INTRACRANIAL PRESSURE MONITOR receive FDA 510(k) clearance?

TM-5 INTRACRANIAL PRESSURE MONITOR received FDA 510(k) clearance on 1980-11-12, under 510(k) number K802149.

Who is the listed applicant for TM-5 INTRACRANIAL PRESSURE MONITOR?

The FDA 510(k) record lists Nicolet Biomedical Instruments as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TM-5 INTRACRANIAL PRESSURE MONITOR?

The FDA product code for TM-5 INTRACRANIAL PRESSURE MONITOR is GWM.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.