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-HS-10-CHET-A 1.0 - 00850011306024 Catalog Number : HS-10-CHET-A 1.0

Device Description : The HS-10-CHET-A 1.0 is a clinical headstage that allows one Ad-Tech Tail Electr The HS-10-CHET-A 1.0 is a clinical headstage that allows one Ad-Tech Tail Electrode (usually consisting of up to 9 electrodes) to interface with the ATLAS Neurophysiology System.

Device Class : 2

Duns Number: 933200842

Premarket Exempt : No

Product Code : OMC

Prescription Use : Yes

Device Count : 1

ATLAS-HS-18-CHET-A 1.0 - 00850011306031 Catalog Number : HS-18-CHET-A 1.0

Device Description : The HS-18-CHET-A 1.0 is a clinical headstage that allows one Ad-Tech Tail Electr The HS-18-CHET-A 1.0 is a clinical headstage that allows one Ad-Tech Tail Electrode (usually consisting of up to 16 electrodes) to interface with the ATLAS Neurophysiology System.

Device Class : 2

Duns Number: 933200842

Premarket Exempt : No

Product Code : OMC

Prescription Use : Yes

Device Count : 1

ATLAS TTL Isolator - 00850011306178 Catalog Number : 31-0604-0060

Device Description : The ATLAS TTL Isolator is an optional configuration of the ATLAS Neurophysiology The ATLAS TTL Isolator is an optional configuration of the ATLAS Neurophysiology System that isolates two of the four 8 bit TTL Ports on the front of the system.

Device Class : 2

Duns Number: 933200842

Premarket Exempt : No

Product Code : OMC

Prescription Use : Yes

Device Count : 1

ATLAS Ground Drive - 00850011306185 Catalog Number : 31-0604-0100

Device Description : The Active Ground Drive generates the Active Ground signal based on input select The Active Ground Drive generates the Active Ground signal based on input selected in the Data Acquisition Software.

Device Class : 2

Duns Number: 933200842

Premarket Exempt : No

Product Code : OMC

Prescription Use : Yes

Device Count : 1

ATLAS Patient Event Marker - 00850011306192 Catalog Number : Patient Event Marker

Device Description : The ATLAS Patient Event Marker is an optional configuration of the ATLAS Neuroph The ATLAS Patient Event Marker is an optional configuration of the ATLAS Neurophysiology System that allows the patient to mark an event in the Data Acquisition Software.

Device Class : 2

Duns Number: 933200842

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

High Density Junction Box - B - 00850011306383 Catalog Number : 31-0602-0034

Device Description : Passive adapter with touchproof inputs and a high density output for adapting 3r Passive adapter with touchproof inputs and a high density output for adapting 3rd party electrode interface cables to the ATLAS Neurophysiology System. Version "B" is labeled for connections to electrodes 65-128.

Device Class : 2

Duns Number: 933200842

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

High Density Junction Box - C - 00850011306390 Catalog Number : 31-0602-0035

Device Description : Passive adapter with touchproof inputs and a high density output for adapting 3r Passive adapter with touchproof inputs and a high density output for adapting 3rd party electrode interface cables to the ATLAS Neurophysiology System. Version "C" is labeled for connections to electrodes 129-192.

Device Class : 2

Duns Number: 933200842

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

High Density Junction Box - D - 00850011306406 Catalog Number : 31-0602-0036

Device Description : Passive adapter with touchproof inputs and a high density output for adapting 3r Passive adapter with touchproof inputs and a high density output for adapting 3rd party electrode interface cables to the ATLAS Neurophysiology System. Version "D" is labeled for connections to electrodes 193-256.

Device Class : 2

Duns Number: 933200842

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

High Density Junction Box - E - 00850011306413 Catalog Number : 31-0602-0037

Device Description : Passive adapter with touchproof inputs and a high density output for adapting 3r Passive adapter with touchproof inputs and a high density output for adapting 3rd party electrode interface cables to the ATLAS Neurophysiology System. Version "E" is labeled for connections to electrodes 257-320.

Device Class : 2

Duns Number: 933200842

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

High Density Junction Box - F - 00850011306420 Catalog Number : 31-0602-0038

Device Description : Passive adapter with touchproof inputs and a high density output for adapting 3r Passive adapter with touchproof inputs and a high density output for adapting 3rd party electrode interface cables to the ATLAS Neurophysiology System. Version "F" is labeled for connections to electrodes 321-384.

Device Class : 2

Duns Number: 933200842

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

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