FDA 510(k)

INTEGRA LICOX PTO2 MONITOR

K-Number: K131184 · 2013-08-30

Decision Date2013-08-30

Product CodeGWM

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

INTEGRA LICOX PTO2 MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Integra Lifesciences Corp.. It received FDA 510(k) clearance on 2013-08-30 under 510(k) number K131184. 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 INTEGRA LICOX PTO2 MONITOR?

INTEGRA LICOX PTO2 MONITOR is a medical device that received FDA 510(k) clearance on 2013-08-30. The listed applicant is Integra Lifesciences Corp.. The 510(k) number is K131184.

When did INTEGRA LICOX PTO2 MONITOR receive FDA 510(k) clearance?

INTEGRA LICOX PTO2 MONITOR received FDA 510(k) clearance on 2013-08-30, under 510(k) number K131184.

Who is the listed applicant for INTEGRA LICOX PTO2 MONITOR?

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

What is the FDA product code for INTEGRA LICOX PTO2 MONITOR?

The FDA product code for INTEGRA LICOX PTO2 MONITOR 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.