Standalone 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…
Standalone 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).
Who Else Makes It
Registered in Shaanxi. One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for Standalone | Listed by | Diagnosys LLC, United States |
| FDA product code | GWE |
| Device type | Stimulator, Photic, Evoked Response |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1890 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K863956 |
| Record published | 2023-06-01 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Label carries | serial number |
| Storage | Handling environment temperature -10 to 70 °C; Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment humidity 10 to 100 % RH; Storage environment temperature -10 to 70 °C; Handling environment atmospheric pressure 50 to 106 KiloPascal; Handling environment humidity 10 to 100 % RH |
| UDI direct marking | Exempt |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.