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K Number
K002765

Validate with FDA (Live)

Device Name
LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPE
Manufacturer
INTEGRA NEUROSCIENCES
Date Cleared
2000-11-24

(80 days)

Product Code
GWM
Regulation Number
882.1620
Type
Traditional
Panel
Neurology
Reference & Predicate Devices
N/A
Predicate For
K013005,K020285,K020558,K032337,K040235,K130529,K131184,K141869
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 882.1620 Intracranial pressure monitoring device.

(a)
Identification. An intracranial pressure monitoring device is a device used for short-term monitoring and recording of intracranial pressures and pressure trends. The device includes the transducer, monitor, and interconnecting hardware.(b)
Classification. Class II (performance standards).