DIAGNOSYS LLC

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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

Stimulator, Photic, Evoked Response (GWE) (10)

Premarket Exempt

Clear

Espion - 00850594007318 Catalog Number :

Device Description : Profile System; with Xenon ColorDome and ColorBurst and Mini OLED with table sta Profile System; with Xenon ColorDome and ColorBurst and Mini OLED with table stand 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-2-T

Device Class : 2

Duns Number: 131488467

Premarket Exempt : No

Product Code : GWE

Prescription Use : No

Device Count : 1

Espion - 00850594007325 Catalog Number :

Device Description : Profile System; with Non-Xenon ColorDome on OR Arm and ColorBurst and Mini OLED Profile System; with Non-Xenon ColorDome on OR Arm and ColorBurst and Mini OLED with table stand 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-CDNR-2-T

Device Class : 2

Duns Number: 131488467

Premarket Exempt : No

Product Code : GWE

Prescription Use : No

Device Count : 1

Espion - 00850594007332 Catalog Number :

Device Description : Profile System; with Xenon ColorDome on an OR Arm and ColorBurst and Mini OLED w Profile System; with Xenon ColorDome on an OR Arm and ColorBurst and Mini OLED with table stand 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-2-T

Device Class : 2

Duns Number: 131488467

Premarket Exempt : No

Product Code : GWE

Prescription Use : No

Device Count : 1

Espion - 00850594007349 Catalog Number :

Device Description : Profile System; with 23" Monitor is a clinical and research visual electrophysio Profile System; with 23" 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-B-1-23F-N-N

Device Class : 2

Duns Number: 131488467

Premarket Exempt : No

Product Code : GWE

Prescription Use : No

Device Count : 1

Espion - 00850594007356 Catalog Number :

Device Description : Profile System; with 23" Monitor and ColorBurst is a clinical and research visua Profile System; with 23" Monitor and ColorBurst 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-1-23F-2-N

Device Class : 2

Duns Number: 131488467

Premarket Exempt : No

Product Code : GWE

Prescription Use : No

Device Count : 1

Espion - 00850594007363 Catalog Number :

Device Description : Profile System; with 23" Monitor on an OR Arm is a clinical and research visual Profile System; with 23" Monitor on an OR 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-1-23R-N-N

Device Class : 2

Duns Number: 131488467

Premarket Exempt : No

Product Code : GWE

Prescription Use : No

Device Count : 1

Espion - 00850594007370 Catalog Number :

Device Description : Profile System; with 23" Monitor on an OR Arm and ColorBurst is a clinical and r Profile System; with 23" Monitor on an OR Arm and ColorBurst 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-1-23R-2-N

Device Class : 2

Duns Number: 131488467

Premarket Exempt : No

Product Code : GWE

Prescription Use : No

Device Count : 1

Espion - 00850594007387 Catalog Number :

Device Description : Profile System; with 32" Monitor and Mini OLED with table stand is a clinical an Profile System; with 32" Monitor and Mini OLED with table stand 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-1-32F-N-T

Device Class : 2

Duns Number: 131488467

Premarket Exempt : No

Product Code : GWE

Prescription Use : No

Device Count : 1

Espion - 00850594007394 Catalog Number :

Device Description : Profile System; with 32" Monitor and ColorBurst and Mini OLED with table stand i Profile System; with 32" Monitor and ColorBurst and Mini OLED with table stand 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-1-32F-2-T

Device Class : 2

Duns Number: 131488467

Premarket Exempt : No

Product Code : GWE

Prescription Use : No

Device Count : 1

Espion - 00850594007400 Catalog Number :

Device Description : Profile System; with 23" Monitor and Mini OLED with table stand is a clinical an Profile System; with 23" Monitor and Mini OLED with table stand 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-1-23F-N-T

Device Class : 2

Duns Number: 131488467

Premarket Exempt : No

Product Code : GWE

Prescription Use : No

Device Count : 1

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