Devices

NicoletOne

Model / Serial
ON040060, ON050120, ON050130, ON050168, ON050186, ON050197, ON050199, ON050203, ON050206, ON050212, ON050220, ON050231, ON060232, ON060243, ON060254, ON060256, ON060257, ON060269, ON060270, ON060272, ON060275, ON060276, ON060277, ON060278, ON060279, ON060280, ON060288, ON060290, ON060291, ON060292, ON060299, ON070301, ON070308.
Product Classification
Neurological Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Dsitribution - USA, Germany, Netherlands, Kuwait, Japan, Ireland, and China.
Product Description
Viasys Healthcare NicoletOne ICU Monitor, Modular Neurodiagnostic System (containing Axiomtek Panel PC computer system), released and installed between December 2004 and March 2007 (Axiomtek Panel PC Model Number: 2147-671) VIASYS NeuroCare Part Numbers: 842-673800, 842-673900, 982A0421 and 982A0422. || Manufactured, designed, developed and marketed by VIASYS NeuroCare Inc., Madison, WI 53711
Manufacturer
Nicolet Biomedical Div of Viasys Healthcare
1 Event
- Recall of NicoletOne

Manufacturer

Nicolet Biomedical Div of Viasys Healthcare

Manufacturer Address
Nicolet Biomedical Div of Viasys Healthcare, 5225 Verona Rd, Madison WI 53711-4497
Source
USFDA

15 devices with a similar name

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Device Recall NicoletOne monitoring system version 5.20 software

Model / Serial
NicoletOne Version 5.20 software released and installed after August 07, 2006.
Product Classification
Neurological Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide, including USA, Belgium, Chile, Denmark, Italy, Japan, Poland, and Spain.
Product Description
NicoletOne version 5.20 software (also known as NicoletOne Version 5.2 Software) used with the NicoletOne LTM, Sleep, nEEG, vEEG and ICU monitoring Systems.
Manufacturer
Nicolet Biomedical Div of Viasys Healthcare

NicoletOne software with Cortical Stimulator License

Model / Serial
Manufacturer
CareFusion 209 Inc

EEG recorder NicoletOne® System

Model / Serial
Product Description
Medical electronics / Electromedical devices
Manufacturer
CareFusion

NicoletOne Software v5.60.2 through v5.71. with Cortical Stimulator License, Nicolet Cortical Sti...

Model / Serial
Product Description
Medical electronics / Electromedical devices
Manufacturer
Carefusion Corporation

the NicoletOne Software v5.94

Model / Serial
Product Description
Medical electronics / Electromedical devices - electrodiagnostics
Manufacturer
Natus Neurology lncorporated

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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