Devices

NicoletOne Software v5.94

Model / Serial
Serial numbers include TS150456M, TR150171M, TR150172M, 1TR150173M, TR150174M, TS150451M, TS150452M, TR150170M, UH150119M, TR150169M, UR150226M, UR150227M, UR150228M, UR150229M, TS150455M, TS150457M, TS150458M, TS150454M, TS150453M, UC150184M, PN151700M, SJ150272M, TT150134M, PN151699M, UR150230M, UR150231M, and SJ150271M.
Product Classification
Neurological Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution. US nationwide, INDIA, ROMANIA, DENMARK, JAPAN, AUSTRALIA, RUSSIA, BANGLADESH, SRI LANKA, BRUNEI, and UNITED ARAB EMIRATES.
Product Description
NicoletOne Software v5.94, Catalog/Part Number: 482-649600. || The NicoletOne data acquisition and review system, either with or without synchronous digital video. The system is intended for medical purposes to record, measure, store and display full band (FbEEG) cerebral EEG and extracerebral activity for Clinical EEG, Electrocorticography (EcOG), Long Term Monitoring (LTM), Intensive Care Unit (ICU) monitoring and Polysomnography (PSG) Sleep studies. While the Nicolet Neurodiagnostic systems are capable of displaying signals, such as Sp02 and EKG, the system is NOT intended for monitoring such signals for the preservation of life, The Nicolet Neurodiagnostic systems are intended to acquire, analyze, and display data
Manufacturer
Natus Neurology Inc
1 Event
- Recall of NicoletOne Software v5.94

Manufacturer

Natus Neurology Inc

Manufacturer Address
Natus Neurology Inc, 3150 Pleasant View Rd, Middleton WI 53562-4800
Manufacturer Parent Company (2017)
Natus Medical Incorporated
Source
USFDA

One device with a similar name

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the NicoletOne Software v5.94

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

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