Device Description : A non-sterile electrical conductor intended to be applied adjacent to the eye to A non-sterile electrical conductor intended to be applied adjacent to the eye to transmit an electrical signal during an evaluation of the eye's retina. It is typically in the form of a conductive thread that is laid along the lower eyelid in contact with the tear film and cornea. The general device that records this electrical activity is the electroretinograph (ERG). This is a single-use device.
Device Class : 2
Duns Number: 131488467
Premarket Exempt : No
Prescription Use : No
Device Description : The Profle System with Xenon ColorDome & ColorBurst is a clinical and research v The Profle System with Xenon ColorDome & 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). It's product configuration D310-R-1-CDXS-2-N.
Device Class : 2
Duns Number: 131488467
Premarket Exempt : No
Prescription Use : No
Device Description : The Profile System; with Non-Xenon ColorDome on an Operating Room Arm is a clini The Profile System; with Non-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-R-1-CDNR-N-N
Device Class : 2
Duns Number: 131488467
Premarket Exempt : No
Prescription Use : No
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-R-1-CDXR-N-N
Device Class : 2
Duns Number: 131488467
Premarket Exempt : No
Prescription Use : No
Device Description : Profile System; with ColorBurst is a clinical and research visual electrophysiol Profile System; with 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-R-1-NNNN-2-N
Device Class : 2
Duns Number: 131488467
Premarket Exempt : No
Prescription Use : No
Device Description : Profile System; with Non-Xenon ColorDome and ColorBurst is a clinical and resear Profile System; with Non-Xenon ColorDome 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-R-1-CDNS-2-N
Device Class : 2
Duns Number: 131488467
Premarket Exempt : No
Prescription Use : No
Device Description : Profile System; with Xenon ColorDome and ColorBurst is a clinical and research v Profile System; with Xenon ColorDome 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-R-1-CDXS-2-N
Device Class : 2
Duns Number: 131488467
Premarket Exempt : No
Prescription Use : No
Device Description : Profile System; with Xenon ColorDome; 220V is a clinical and research visual ele Profile System; with Xenon ColorDome; 220V 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-R-2-CDXS-N-N
Device Class : 2
Duns Number: 131488467
Premarket Exempt : No
Prescription Use : No
Device Description : Profile System; with 32" Monitor is a clinical and research visual electrophysio Profile System; with 32" 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-1-32F-N-N
Device Class : 2
Duns Number: 131488467
Premarket Exempt : No
Prescription Use : No
Device Description : Profile System; with 32" Monitor and ColorBurst is a clinical and research visua Profile System; with 32" 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-1-32F-2-N
Device Class : 2
Duns Number: 131488467
Premarket Exempt : No
Prescription Use : No