NEURALYNX, INC.

Address:105 Commercial Dr,Bozeman,MT,59715,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Cable, Electrode (IKD) (7) Reduced- Montage Standard Electroencephalograph (OMC) (2) Amplifier, Physiological Signal (GWL) (1)

Premarket Exempt

Yes No

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High Density Tether - 10850011306373 Catalog Number : 31-0202-0001

Device Description : The High Density Tether is a flexible cable to connect the High Density Junction The High Density Tether is a flexible cable to connect the High Density Junction Box to the ATLAS Neurophysiology System. The High Density Tether is a component of the ATLAS Neurophysiology System.

Device Class : 2

Duns Number: 933200842

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

ATLAS TPSS Cable - 10867718000206 Catalog Number : 31-0602-0027

Device Description : The ATLAS TPSS Cable is an adapter that allows signals from an electrode interfa The ATLAS TPSS Cable is an adapter that allows signals from an electrode interface to be recorded by not only the ATLAS Neurophysiology System by Neuralynx, Inc. but also other neurophysiology recording systems with touch proof connectors. The ATLAS TPSS Cable shares the outputs from the electrode interface and splits them to both systems to be digitized.

Device Class : 2

Duns Number: 933200842

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

ADPT-NKSS-DRS-A AdapterCable - 10867718000213 Catalog Number : 31-0602-0002

Device Description : The ADPT-NKSS-DRS-A is an adapter cable that allows signals from an electrode in The ADPT-NKSS-DRS-A is an adapter cable that allows signals from an electrode interface to be recorded by not only the ATLAS Neurophysiology System (K110967) by Neuralynx, Inc. but also the JE-120A Amplifier (K113117), by Nihon Kohden Corporation.

Device Class : 2

Duns Number: 933200842

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

ADPT-NKSS-DRS-BCD Adapter Cable - 10867718000220 Catalog Number : 31-0602-0003

Device Description : The ADPT-NKSS-DRS-BCD is an adapter that allows signals from an electrode interf The ADPT-NKSS-DRS-BCD is an adapter that allows signals from an electrode interface to be recorded by not only the ATLAS Neurophysiology System (K110967) by Neuralynx, Inc. but also the JE-120A Amplifier (K113117), by Nihon Kohden Corporation.

Device Class : 2

Duns Number: 933200842

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

ADPT-NKSS-Y-A Adapter Cable - 10867718000237 Catalog Number : 31-0602-0007

Device Description : The ADPT-NKSS-Y-A is an adapter cable that allows signals from an electrode inte The ADPT-NKSS-Y-A is an adapter cable that allows signals from an electrode interface by Nihon Kohden Corporation to be recorded by both the JE-120A Amplifier by Nihon Kohden Corporation and the JE-212A Amplifier by Nihon Kohden Corporation.

Device Class : 2

Duns Number: 933200842

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

ADPT-NKSS-Y-B Adapter Cable - 10867718000244 Catalog Number : 31-0602-0008

Device Description : The ADPT-NKSS-Y-B is an adapter cable that allows signals from an electrode inte The ADPT-NKSS-Y-B is an adapter cable that allows signals from an electrode interface by Nihon Kohden Corporation to be recorded by both the JE-120A Amplifier by Nihon Kohden Corporation and the JE-212A Amplifier by Nihon Kohden Corporation.

Device Class : 2

Duns Number: 933200842

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

ADPT-NKSS-Y-C Adapter Cable - 10867718000251 Catalog Number : 31-0602-0009

Device Description : The ADPT-NKSS-Y-C is an adapter cable that allows signals from an electrode inte The ADPT-NKSS-Y-C is an adapter cable that allows signals from an electrode interface by Nihon Kohden Corporation to be recorded by both the JE-120A Amplifier by Nihon Kohden Corporation and the JE-212A Amplifier by Nihon Kohden Corporation.

Device Class : 2

Duns Number: 933200842

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

ATLAS Neurophysiology System - 10867718000268 Catalog Number : ATLAS Neurophysiology System

Device Description : Electroencephalographic monitoring system, stationary

Device Class : 2

Duns Number: 933200842

Premarket Exempt : No

Product Code : OMC

Prescription Use : Yes

Device Count : 1

Pegasus - 10867718000275 Catalog Number : Pegasus

Device Description : Pegasus is the software component of the ATLAS Neurophysiology System that inter Pegasus is the software component of the ATLAS Neurophysiology System that interfaces with the amplifier. It is used to display, store and archive EEG signals and allow user-only annotation and marking. Pegasus does not analyze EEG or automatically detect events.

Device Class : 2

Duns Number: 933200842

Premarket Exempt : No

Product Code : OMC

Prescription Use : Yes

Device Count : 1

ATLAS-HS-36-CHET-D18 - 10867718000299 Catalog Number : 31-0601-0082

Device Description : The ATLAS-HS-36-CHET-D18 is a clinical headstage that allows two 18 contact DIXI The ATLAS-HS-36-CHET-D18 is a clinical headstage that allows two 18 contact DIXI electrode connectors to interface with the ATLAS Data Acquisition System. The ATLAS-HS-36-CHET-D18 uses electronic components to buffer single unit activity sensed by the electrodes and sends it to the ATLAS Data Acquisition System to be digitized.

Device Class : 2

Duns Number: 933200842

Premarket Exempt : Yes

Product Code : GWL

Prescription Use : Yes

Device Count : 1

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