Bravo Multi-Modality System

• • Terminated Z-1256-2010 FDA Unclassified (pre-2012) ·initiated 8 Mar 2010

  CareFusion NeuroCare is voluntarily implementing a field correction to delete certain NicoletOne software protocols, which users may interpret incorrectly when conducting patient evaluations. This may result in the misinterpretation of the left versus right side of the brain. Users are being provided with instructions for removing these protocols and verifying that the deletion has been prop

• • Terminated Z-2459-2008 FDA Unclassified (pre-2012) ·initiated 13 Jun 2008

  NicoletOne 5.30.2 Software when used with CSeries amplifiers in Fixed Room LTM Configurations with patient room kits. Cardinal Health NeuroCare has confirmed that the 3rd party room relay connected to the A2 wall plate does not always activate if the patient event button connected to the CSeries Amplifier is pressed twice within one second.

• • Terminated Z-2389-2008 FDA Unclassified (pre-2012) ·initiated 5 Jun 2008

  Cardinal Health NeuroCare is implementing a voluntary field correction to replace a quantity of photic adapter cables, part number 085-463700, used to connect the NicLED Photic Strobe option, part number 698-625500, with NicoletOne EEG system. The photic adapter cable has a wiring error which delivers a reduced voltage and results in a decreased intensity of the NicLED photic. This reduced intensi

• • Terminated Z-0380-2007 FDA Unclassified (pre-2012) ·initiated 25 Aug 2006

  A software anomaly exists in the 5.20.1038 NicoletOne LTM, Sleep, nEEG, vEEG and ICU Monitor systems using the M, and/or C series amplifiers. If this anomaly occurs, the system will display the data for channel one in all channels on NicoletOne LTM, Sleep, nEEG, vEEG or ICU Monitor systems.

510(k) Number

K991054 ↗

FDA Product Code

GWQ

Device Class

Class II

Regulation

21 CFR Part 882.1400

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K013419 Active Cleared 20 Dec 2001

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• Caredop II

  Class II

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  Class II

  FDA 510(k) K020955 Active Cleared 17 Apr 2002

See all devices from Nicolet Biomedical, Inc. →

• What is the primary purpose of the Bravo Multi-Modality System?

  This device is a full-montage standard electroencephalograph designed to record and monitor the electrical activity of the brain. It is intended for use in clinical neurological assessments.

• What is the regulatory classification of this device?

  The Bravo Multi-Modality System is classified as a Class 2 neurology device under regulation number 882.1400. It has received FDA 510(k) clearance through the traditional pathway.

• Who is the manufacturer of the Bravo Multi-Modality System?

  The device is manufactured by Nicolet Biomedical, Inc., which is based in Madison, Wisconsin.