Neurosensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit/System, Models Ns-P, Ns-100

• • Terminated Z-0339-06 FDA Unclassified (pre-2012) ·initiated 8 Sep 2005

  Certain Model NS-P probes contained in the NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit may allow an Intracranial Pressure (ICP) drift of up to 5 mmHg during the first 24 hours of monitoring ICP. This is outside the products labeling specification of 2 mmHg maximum ICP drift within the first 24 hours of monitoring.

510(k) Number

K050720 ↗

FDA Product Code

GWM

Device Class

Class II

Regulation

21 CFR Part 882.1620

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Auragen Cortical Surface Electrodes

  Class II

  FDA 510(k) K082250 Active Cleared 10 Oct 2008

• Camino Single Parameter Monitor, Model Spm-1

  Class II

  FDA 510(k) K031086 Active Cleared 14 May 2003

• Licox Cmp Monitor-AC3.1, Licox Imc Oxygen Catheters-CC1, CC1.SB Luicox Imc Introducer Kits-Im, IM2, IM3, II1 Licoximc Tempe

  Class II

  FDA 510(k) K002765 Active Cleared 24 Nov 2000

• Camino Intracranial Pressure Monitoring Catheter with Licox Imc Bolt Fitting, Model 110-4l

  Class II

  FDA 510(k) K022553 Active Cleared 20 Aug 2002

• Selector Quantum Ultrasonic Aspirator System

  Unclassified

  FDA 510(k) K042277 Active Cleared 29 Sep 2004

• Selector Integra Ultrasonic Surgical Aspirator, Model Om 1530000M3

  Unclassified

  FDA 510(k) K021989 Active Cleared 13 Sep 2002

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