Atlas FDA

LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPE

FDA 510(k) clearance K002765 · decided 2000-11-24

Clearance details

K-number
K002765
Device name
LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPE
Applicant
Integra Neurosciences
Decision
Substantially Equivalent
Date received
2000-09-05
Decision date
2000-11-24
Days to decision
80 days
Clearance type
Traditional
Product code
GWM
Device class
2
Regulation number
882.1620
Medical specialty
Neurology
Advisory committee
Neurology
Location
San Diego, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

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Integra Licox Brain Tissue Oxygen Monitoring Integra Licox Recon Tissue Oxygen Monitoring recall (Z-0831-2015)Integra LifeSciences Corp.2014-12-18
LICOX CMP Tissue Oxygen Monitor; Catalog numbers REF AC31. Manufacturer GMS Gesellschaft f recall (Z-1518-2011)Integra LifeSciences Corp.2011-03-03
LICOX Complete Brain IMC Probe Kit, Model IM3.ST C recall (Z-0622-05)Integra Neuro Sciences2005-03-15