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) (6) Reduced- Montage Standard Electroencephalograph (OMC) (4)

Premarket Exempt

No Yes

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ATLAS HC HEADBOX - 10850011306052 Catalog Number : 31-0601-0010

Device Description : The ATLAS HC Headbox is a clinical headbox that allows a CA-105 waveguard™ EEG C The ATLAS HC Headbox is a clinical headbox that allows a CA-105 waveguard™ EEG Cap by ANT Neuro to interface with the ATLAS Neurophysiology System by Neuralynx.

Device Class : 2

Duns Number: 933200842

Premarket Exempt : No

Product Code : OMC

Prescription Use : Yes

Device Count : 1

ATLAS NK HEADBOX - 10850011306069 Catalog Number : 31-0601-0017

Device Description : The ATLAS NK Headbox allows JE-125A, JE-225A, JE-226A, JE-227A, and JE-228A Mini The ATLAS NK Headbox allows JE-125A, JE-225A, JE-226A, JE-227A, and JE-228A Mini Flat Junction Boxes by Nihon Kohden Corporation (NKC) to interface with the ATLAS Neurophysiology System by Neuralynx and JE-120A or JE-212A Amplifier by Nihon Kohden Corporation through the ATLAS NKSS Cable (also by Neuralynx).

Device Class : 2

Duns Number: 933200842

Premarket Exempt : No

Product Code : OMC

Prescription Use : Yes

Device Count : 1

TETH-XTN-MM-1 - 10850011306076 Catalog Number : 31-0613-0002

Device Description : The TETH-XTN-MM-1 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

TETH-XTN-MM-2 - 10850011306083 Catalog Number : 31-0613-0003

Device Description : The TETH-XTN-MM-2 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

TETH-XTN-MM-5 - 10850011306090 Catalog Number : 31-0613-0004

Device Description : The TETH-XTN-MM-5 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

TETH-XTN-MM-8 - 10850011306106 Catalog Number : 31-0613-0005

Device Description : The TETH-XTN-MM-8 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

TETHER INTERCONNECT - 10850011306120 Catalog Number : 31-0602-0004

Device Description : The TETHER INTERCONNECT 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

Modular Headstage-36 - 10850011306137 Catalog Number : 31-0601-0091

Device Description : The Modular Headstage-36 is a clinical headstage that connects to one of several The Modular Headstage-36 is a clinical headstage that connects to one of several modular electrode interfaces to connect electrodes from various manufacturers to the ATLAS Neurophysiology System. The Modular Headstage-36 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 : No

Product Code : OMC

Prescription Use : Yes

Device Count : 1

ATLAS COMBO BOARD - 10850011306144 Catalog Number : 31-0605-0117

Device Description : The ATLAS Combo Board combines the functionality of the ATLAS Hybrid Input Board The ATLAS Combo Board combines the functionality of the ATLAS Hybrid Input Board and ATLAS DRS-36 Board onto a single board, meaning the Digital Reference Selection and Analog to Digital Conversion for 32 electrodes is combined into a single slot.

Device Class : 2

Duns Number: 933200842

Premarket Exempt : No

Product Code : OMC

Prescription Use : Yes

Device Count : 1

ATLAS CHET ADAPTER - 10850011306151 Catalog Number : 31-0602-0028

Device Description : The ATLAS CHET Adapter is an optional configuration of the ATLAS Neurophysiology The ATLAS CHET Adapter is an optional configuration of the ATLAS Neurophysiology System that allows up to 4 clinical headstages to interface with the ATLAS Acquisition Amplifier.

Device Class : 2

Duns Number: 933200842

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

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