DIAGNOSYS LLC

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Device Description : Profile System; with Xenon ColorDome on an Operating Room Arm is a clinical and Profile System; with Xenon ColorDome on an Operating Room Arm 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-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 : Cart-only, no control unit, no power unit, with 27" Monitor is a clinical and re Cart-only, no control unit, no power unit, with 27" Monitor 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-N-3-27F-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 System; with Xenon ColorDome on an Operating Room Arm and ColorBurst (wi Profile System; with Xenon ColorDome on an Operating Room Arm and ColorBurst (with stand) and Mini OLED with extendable arm 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-CDXR-1-X

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 Mini OLED on extendable arm is a clinical a Profile System; with 27" Monitor and Mini OLED on extendable arm 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-B-1-27F-N-X

Device Class : 2

Duns Number: 131488467

Premarket Exempt : No

Product Code : GWE

Prescription Use : No

Device Count : 1

- Catalog Number :

Device Description : E3 System; with Xenon ColorDome and 27" Monitor is a clinical and research visua E3 System; with Xenon ColorDome and 27" Monitor 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-CDXSL-27-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 : E3 System; with Mini OLED, No computer is a clinical and research visual electro E3 System; with Mini OLED, 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: D315-6-1-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; with Mini OLED and Portable computer is a clinical and research visua E3 System; with Mini OLED and Portable 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: D315-6-2-P

Device Class : 2

Duns Number: 131488467

Premarket Exempt : No

Product Code : GWE

Prescription Use : No

Device Count : 1

- Catalog Number :

Device Description : E3 Console 32-Bit Amplifier Amplifier Stand All-in-One Touch Screen Computer wit E3 Console 32-Bit Amplifier Amplifier Stand All-in-One Touch Screen Computer with Espion Software and International Accessory Kit 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: D315-3-2-R-4-D

Device Class : 2

Duns Number: 131488467

Premarket Exempt : No

Product Code : GWE

Prescription Use : No

Device Count : 1

- Catalog Number :

Device Description : E3 Console, 32-bit amplifier, amplifier stand, portable computer with Espion Sof E3 Console, 32-bit amplifier, amplifier stand, portable computer with Espion Software and Accessory Kit 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: D315-3-1-R-1-P

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 on an Operating Room Arm; No Power supply, Profile System; with Xenon ColorDome on an Operating Room Arm; No Power supply, 110V Cart 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-3-CDXR-N-N

Device Class : 2

Duns Number: 131488467

Premarket Exempt : No

Product Code : GWE

Prescription Use : No

Device Count : 1