23 results
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20ms
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Sources: EU EUDAMED, US FDA
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Country: Canada
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CTF SYSTEMS INC, WHOLE-CORTEX MEG SYSTEM (WITH OPTIONAL EEG SUBSYSTEM)
FDA 510(k)
FDA Class 2
·Neurology
84 CHANNEL EEG
FDA 510(k)
FDA Class 2
·Neurology
80 CHANNEL EEG
FDA 510(k)
FDA Class 2
·Neurology
EXCEL AMBULATORY EEG
FDA 510(k)
FDA Class 2
·Neurology
VEEGix EEG System
FDA 510(k)
FDA Class 2
·Neurology
HARMONE-SCHWARZER EEG SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
XLTEK EMU40EX EEG Headbox
FDA 510(k)
FDA Class 2
·Neurology
EEG WITH VIDEO, MODEL EX-NW
FDA 510(k)
FDA Class 2
·Neurology
XLTEK EMU40 EEG HEADBOX, MODEL PK1072
FDA 510(k)
FDA Class 2
·Neurology
EEG WITH VIDEO, MODEL EX-NW
FDA 510(k)
FDA Class 2
·Neurology
96 CHANNEL EEG HEADBOX MODEL EMU96
FDA 510(k)
FDA Class 2
·Neurology
EEG SPIKE AND EVENT DETECTOR MODULE
FDA 510(k)
FDA Class 2
·Neurology
64 CHANNEL EEG / MODEL NUMBER EX-NW-64
FDA 510(k)
FDA Class 2
·Neurology
128 CHANNEL EEG HEADBOX, MODEL EX-NW-128
FDA 510(k)
FDA Class 2
·Neurology
WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS (PROPOSED)
FDA 510(k)
FDA Class 2
·Neurology
EPWorks software used in the Protektor 32 Product Usage: Uses electroencephalography (EEG), evoked potentials (EP), electromyography (EMG) and transcranial motor evoked potentials (TcMEP) stimulation techniques to provide healthcare professionals with information to help assess patients neurological status during surgery.
FDA Enforcement
Class II
·Terminated·Natus Medical Incorporated·February 18, 2015
REAL PATIENT EXCEL NEUROWORK, MODEL EX-RP-EEG (PROPOSED)
FDA 510(k)
FDA Class 2
·Neurology
REAL PATIENT AMBULATORY EEG, MODEL EX-AMB-RP (PROPOSED)
FDA 510(k)
FDA Class 2
·Neurology
REAL PATIENT WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS-RP (PROPOSED)
FDA 510(k)
FDA Class 2
·Neurology
REAL PATIENT REAL PATIENT 128 CHANNEL EEG HEADBOX, MODEL EX-NW-128-RP
FDA 510(k)
FDA Class 2
·Neurology