DIAGNOSYS LLC

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Device Description : Profile Gold System; with Xenon ColorDome is a clinical and research visual elec Profile Gold System; with Xenon ColorDome is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing displaying and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes).Configuration: D310-G-1-CDXS-N-N

Device Class : 2

Duns Number: 131488467

Premarket Exempt : No

Product Code : GWE

Prescription Use : No

Device Count : 1

- Catalog Number :

Device Description : E3 System, 110 Volt power supply, Envoy Mini-OLED on a table stand, No computer E3 System, 110 Volt power supply, Envoy Mini-OLED on a table stand, No computer is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing displaying and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes).Configuration: D315-1-1-NNNNN-NN-N-T-N

Device Class : 2

Duns Number: 131488467

Premarket Exempt : No

Product Code : GWE

Prescription Use : No

Device Count : 1

- Catalog Number :

Device Description : E3 System, 110 Volt power supply, ColorDome with Xenon & desktop OR stand (inclu E3 System, 110 Volt power supply, ColorDome with Xenon & desktop OR stand (includes long cable), with power supply, and chin rest, Desktop computer & Espion Software is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing displaying and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes).Configuration: D315-1-1-CDXRL-NN-N-N-D

Device Class : 2

Duns Number: 131488467

Premarket Exempt : No

Product Code : GWE

Prescription Use : No

Device Count : 1

- Catalog Number :

Device Description : Profile System; with Non-Xenon ColorDome and 220V Power Supply is a clinical and Profile System; with Non-Xenon ColorDome and 220V Power Supply is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing displaying and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes).Configuration: D310-G-2-CDNS-N-N

Device Class : 2

Duns Number: 131488467

Premarket Exempt : No

Product Code : GWE

Prescription Use : No

Device Count : 1

- Catalog Number :

Device Description : Profile System; with no stimulator and 110V Power Supply is a clinical and resea Profile System; with no stimulator and 110V Power Supply is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing displaying and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes).Configuration: D310-G-1-NNNN-N-N

Device Class : 2

Duns Number: 131488467

Premarket Exempt : No

Product Code : GWE

Prescription Use : No

Device Count : 1

- Catalog Number :

Device Description : Profile System; with Xenon ColorDome and 100 Volt power supply is a clinical and Profile System; with Xenon ColorDome and 100 Volt power supply is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing displaying and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes).Configuration: D310-G-5-CDXR-N-N

Device Class : 2

Duns Number: 131488467

Premarket Exempt : No

Product Code : GWE

Prescription Use : No

Device Count : 1

- Catalog Number :

Device Description : Profile System; with 27" Monitor and 100 Volt power supply is a clinical and res Profile System; with 27" Monitor and 100 Volt power supply is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing displaying and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes).Configuration: D310-G-5-27F-N-N

Device Class : 2

Duns Number: 131488467

Premarket Exempt : No

Product Code : GWE

Prescription Use : No

Device Count : 1

- Catalog Number :

Device Description : Profile is a clinical and research visual electrophysiology system that function Profile is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing displaying and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes).

Device Class : 2

Duns Number: 131488467

Premarket Exempt : No

Product Code : GWE

Prescription Use : No

Device Count : 1

- Catalog Number :

Device Description : E3 is a clinical and research visual electrophysiology system that functions by E3 is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing displaying and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes).

Device Class : 2

Duns Number: 131488467

Premarket Exempt : No

Product Code : GWE

Prescription Use : No

Device Count : 1

- Catalog Number :

Device Description : Attache is a clinical and research visual electrophysiology system that function Attache is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing displaying and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes).

Device Class : 2

Duns Number: 131488467

Premarket Exempt : No

Product Code : GWE

Prescription Use : No

Device Count : 1