Atlas FDA

LICOX PMO BRAIN MONITORING SYSTEM

FDA 510(k) clearance K040235 · decided 2004-04-20

Clearance details

K-number
K040235
Device name
LICOX PMO BRAIN MONITORING SYSTEM
Applicant
Integra LifeSciences Corporation
Decision
Substantially Equivalent
Date received
2004-02-02
Decision date
2004-04-20
Days to decision
78 days
Clearance type
Traditional
Product code
GWM
Device class
2
Regulation number
882.1620
Medical specialty
Neurology
Advisory committee
Neurology
Location
Planisboro, NJ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Integra Licox Brain Tissue Oxygen Monitoring Integra Licox Recon Tissue Oxygen Monitoring recall (Z-0831-2015)Integra LifeSciences Corp.2014-12-18
Integra Licox Brain Tissue Oxygen Monitoring; 1 x Complete Brain Probe Kit REF IP1.P Rx On recall (Z-0054-2014)Integra LifeSciences Corp.2013-10-23
Integra Licox Brain Tissue Oxygen Monitoring; 1 x Dual Lumen Introducer Kit REF IP2; Rx On recall (Z-0055-2014)Integra LifeSciences Corp.2013-10-23
Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IP2.P Rx Onl recall (Z-0056-2014)Integra LifeSciences Corp.2013-10-23
Inegra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Tunneling Probe Kit REF IT2 recall (Z-0057-2014)Integra LifeSciences Corp.2013-10-23
Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM1.S Rx Onl recall (Z-0059-2014)Integra LifeSciences Corp.2013-10-23
Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit REF IM2_EU Rx O recall (Z-0060-2014)Integra LifeSciences Corp.2013-10-23
Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit REF IM2.S_.EU R recall (Z-0061-2014)Integra LifeSciences Corp.2013-10-23
Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM3.S_.EU Rx recall (Z-0062-2014)Integra LifeSciences Corp.2013-10-23
Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM3.ST_.EU R recall (Z-0063-2014)Integra LifeSciences Corp.2013-10-23
Licox Brain PMO Probe Kit; Ref IP2.P; Multiparameter Monitoring Oxygen + ICP Channel: Cont recall (Z-0161-2011)Integra LifeSciences Corp.2010-10-28
Integra, Licox Ref 1P2.P; Brain PMO-Probe Kit Rx only; Contains Products: REF 1P2 Bolt kit recall (Z-1422-2010)Integra LifeSciences Corp.2010-04-20

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