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Found 4 results
510(k) Data Aggregation
K Number
K172271Device Name
Trackit T4 EEG Amplifier
Manufacturer
Lifelines Ltd.
Date Cleared
2018-05-04
(280 days)
Product Code
GWQ, GWO
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
Lifelines Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Trackit T4 EEG Amplifier is intended to be used as a front-end amplifier to acquire, store and transmit electrophysiological signals (wireless or cabled).
Device Description
The Trackit T4 EEG Amplifier is a multi-channel electroencephalograph designed for use in routine EEG and lab monitoring applications and due to its small size, can be used in ambulatory applications. In this situation, the EEG electrodes are fitted to the patient by a trained clinician prior to the patient being sent home. No subsequent intervention is required by the patient. Upon completion of the recording, the data which is stored on a memory card is reviewed by a clinician using review and analysis software on a PC. It is a compact USB amplifier which provides 32 channels with internal expansion option) with built-in calibration and electrode impedance measurement. Also provided is a Nonin pulse oximeter interface, a Patient Event input and an Aux DC input. Optional wireless communication is available (Bluetooth and WLAN WiFi). There are two variants of the Trackit T4 EEG Amplifier: - Trackit T4-32 providing 24 referential + 8 poly channels. . - . Trackit T4-68 providing 64 referential + 4 poly channels (using internal expansion board). Plug-on Patient Connection Units (PCUs) provide 32 channel touchproof inputs (model T4-PCU 24+8) or 68 channels (model T4-PCU 64+4). The Amplifier is intended to be connected to a USB port on a PC which is powered from a medically approved power supply. In addition it can be battery powered in ambulatory applications. This equipment is intended only as an adjunct device in patient assessment; it must be used in conjunction with other methods of patient diagnosis. The equipment does not sustain or support life.
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K Number
K151600Device Name
R-40 EEG Amplifier
Manufacturer
LIFELINES LTD.
Date Cleared
2015-10-23
(133 days)
Product Code
GWL, GWQ
Regulation Number
882.1835Why did this record match?
Applicant Name (Manufacturer) :
LIFELINES LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The R-40 EEG Amplifier is intended to be used as a front-end amplifier to acquire, store and transmit electrophysiological signals (wireless or cabled).
Device Description
The R-40 EEG Amplifier is a multi-channel electroencephalograph designed for use in routine EEG and lab monitoring applications.
It is a compact USB 40-channel amplifier which incorporates 32 referential channels and 8 polygraphic channels with built-in calibration and electrode impedance measurement. A Nonin pulse oximeter interface is provided, a Patient Event input, 2 Aux DC inputs and an Electrocap connector. Optional wireless communication is available (Bluetooth and WLAN WiFi).
The Amplifier is intended to be connected to a USB port on a PC which is powered from a medically approved power supply.
This equipment is intended only as an adjunct device in patient assessment; it must be used in conjunction with other methods of patient diagnosis. The equipment does not sustain or support life.
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K Number
K101691Device Name
LIFELINES PHOTIC STIMULATOR
Manufacturer
LIFELINES LTD.
Date Cleared
2010-08-10
(55 days)
Product Code
GWE, DEV
Regulation Number
882.1890Why did this record match?
Applicant Name (Manufacturer) :
LIFELINES LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Lifelines Photic Stimulator is indicated for photic activation of the EEG during an EEG study and in the generation of visual evoked potentials.
Device Description
The Photic Stimulator is a device for generating short-duration flashes of white light by means of a solid-state LED (light emitting diode). The flashes are controlled from a host PC and typically occur over a repetition rate of between 1 and 60Hz.
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K Number
K010460Device Name
LIFELINES TRACKIT
Manufacturer
LIFELINES LTD.
Date Cleared
2001-05-14
(87 days)
Product Code
OLV
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
LIFELINES LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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