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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Espion - 00855730007269

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
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00855730007269 ()


  • Electroretinograph

Espion - 00855730007252

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
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00855730007252 ()


  • Electroretinograph

Espion - 00855730007245

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
DIAGNOSYS LLC
D315
In Commercial Distribution

  • 00855730007245 ()


  • Electroretinograph

Espion - 00855730007238

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
DIAGNOSYS LLC
D315
In Commercial Distribution

  • 00855730007238 ()


  • Electroretinograph

Espion - 00855730007221

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
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00855730007221 ()


  • Electroretinograph

Espion - 00855730007214

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
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00855730007214 ()


  • Electroretinograph

Espion - 00855730007207

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
DIAGNOSYS LLC
D315
In Commercial Distribution

  • 00855730007207 ()


  • Electroretinograph

Espion - 00855730007191

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
DIAGNOSYS LLC
D315
In Commercial Distribution

  • 00855730007191 ()


  • Electroretinograph

Espion - 00855730007184

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
DIAGNOSYS LLC
D315
In Commercial Distribution

  • 00855730007184 ()


  • Electroretinograph

Espion - 00855730007177

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
DIAGNOSYS LLC
D315
In Commercial Distribution

  • 00855730007177 ()


  • Electroretinograph
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