FDA 510(k)

LICOX PMO BRAIN MONITORING SYSTEM

K-Number: K040235 · 2004-04-20

ApplicantIntegra LifeSciences Corporation

Decision Date2004-04-20

Product CodeGWM

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

LICOX PMO BRAIN MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Integra LifeSciences Corporation. It received FDA 510(k) clearance on 2004-04-20 under 510(k) number K040235. 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 LICOX PMO BRAIN MONITORING SYSTEM?

LICOX PMO BRAIN MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2004-04-20. The listed applicant is Integra LifeSciences Corporation. The 510(k) number is K040235.

When did LICOX PMO BRAIN MONITORING SYSTEM receive FDA 510(k) clearance?

LICOX PMO BRAIN MONITORING SYSTEM received FDA 510(k) clearance on 2004-04-20, under 510(k) number K040235.

Who is the listed applicant for LICOX PMO BRAIN MONITORING SYSTEM?

The FDA 510(k) record lists Integra LifeSciences Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LICOX PMO BRAIN MONITORING SYSTEM?

The FDA product code for LICOX PMO BRAIN MONITORING SYSTEM is GWM.

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Official Source

View on FDA Database →

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