Espion
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…
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
1manufacturer
129catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Registered in Shaanxi. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xian Friendship Medical Electronics Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 10 |
Record
| 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 | 2017-02-17 |
| Record revised | 2019-08-13 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
| Storage | Storage environment atmospheric pressure 50 to 106 KiloPascal; Handling environment temperature -10 to 70 °C; Handling environment humidity 10 to 100 % RH; Handling environment atmospheric pressure 50 to 106 KiloPascal; Storage environment temperature -10 to 70 °C; Storage environment humidity 10 to 100 % RH |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| D310 | In distribution | |
| D310 | In distribution | |
| D315 | In distribution | |
| D310 | In distribution | |
| D315 | In distribution | |
| D315 | In distribution | |
| D310 | In distribution | |
| D315 | In distribution | |
| D315 | In distribution | |
| D315 | In distribution | |
| D310 | In distribution | |
| D310 | In distribution | |
| D310 | In distribution | |
| D315 | In distribution | |
| D315 | In distribution | |
| D315 | In distribution | |
| D310 | In distribution | |
| D310 | In distribution | |
| D315 | In distribution | |
| D315 | In distribution | |
| D310 | In distribution | |
| D315 | In distribution | |
| D310 | In distribution | |
| D310 | In distribution | |
| D310 | In distribution | |
| D315 | In distribution | |
| D315 | In distribution | |
| D310 | In distribution | |
| D310 | In distribution | |
| D315 | In distribution | |
| D315 | In distribution | |
| D310 | In distribution | |
| D310 | In distribution | |
| D310 | In distribution | |
| D315 | In distribution | |
| D310 | In distribution | |
| D310 | In distribution | |
| D315 | In distribution | |
| D310 | In distribution | |
| D310 | In distribution | |
| D315 | In distribution | |
| D315 | In distribution | |
| D310 | In distribution | |
| D315 | In distribution | |
| D310 | In distribution | |
| D315 | In distribution | |
| D315 | In distribution | |
| D310 | In distribution | |
| D310 | In distribution | |
| D310 | In distribution | |
| D310 | In distribution | |
| D315 | In distribution | |
| D310 | In distribution | |
| D310 | In distribution | |
| D310 | In distribution | |
| D315 | In distribution | |
| D310 | In distribution | |
| D310 | In distribution | |
| D315 | In distribution | |
| D310 | In distribution | |
| D315 | In distribution | |
| D315 | In distribution | |
| D310 | In distribution | |
| D310 | In distribution | |
| D310 | In distribution | |
| D310 | In distribution | |
| D310 | In distribution | |
| D310 | In distribution | |
| D315 | In distribution | |
| D310 | In distribution | |
| D315 | In distribution | |
| D310 | In distribution | |
| D310 | In distribution | |
| D310 | In distribution | |
| D310 | In distribution | |
| D315 | In distribution | |
| D310 | In distribution | |
| D310 | In distribution | |
| D310 | In distribution | |
| D310 | In distribution | |
| D315 | In distribution | |
| D310 | In distribution | |
| D310 | In distribution | |
| D315 | In distribution | |
| D310 | In distribution | |
| D310 | In distribution | |
| D315 | In distribution | |
| D310 | In distribution | |
| D315 | In distribution | |
| D310 | In distribution | |
| D310 | In distribution | |
| D310 | In distribution | |
| D310 | In distribution | |
| D310 | In distribution | |
| D315 | In distribution | |
| D310 | In distribution | |
| D315 | In distribution | |
| D310 | In distribution | |
| D310 | In distribution | |
| D315 | In distribution | |
| D310 | In distribution | |
| D310 | In distribution | |
| D310 | In distribution | |
| D310 | In distribution | |
| D315 | In distribution | |
| D310 | In distribution | |
| D310 | In distribution | |
| D315 | In distribution | |
| D310 | In distribution | |
| D315 | In distribution | |
| D310 | In distribution | |
| D315 | In distribution | |
| D310 | In distribution | |
| D315 | In distribution | |
| D315 | In distribution | |
| D315 | In distribution | |
| D310 | In distribution | |
| D310 | In distribution | |
| D310 | In distribution | |
| D315 | In distribution | |
| D310 | In distribution | |
| D341 | In distribution | |
| D310 | In distribution | |
| D310 | In distribution | |
| D315 | In distribution | |
| D310 | In distribution | |
| D310 | In distribution | |
| D310 | In distribution | |
| D310 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Utas | L K C Technologies, Inc. | 34 |
| Diopsys® | Diopsys Inc. | 13 |
| Stimulator, Photic, Evoked Response | Medtronic Xomed, Inc. | 6 |
| Natus | Xltek | 4 |
| Micromed | Micromed, Inc. | 4 |
| Lifelines Photic Stimulator | Lifelines Ltd. | 2 |
| RETI-port/scan 21 gamma plus | Roland Consult Stasche & Finger GmbH | 2 |
| Sierra Summit | Cadwell Industries, Inc. | 2 |
| RETI-port/scan 21 delta plus | Roland Consult Stasche & Finger GmbH | 2 |
| Stimulator, Photic, Evoked Response | Medtronic Sofamor Danek, Inc. | 2 |
| RETI-port/scan 21 gamma | Roland Consult Stasche & Finger GmbH | 1 |
| Cascade Pro | Cadwell Industries, Inc. | 1 |
Showing 12 of 41. All products under Stimulator, Photic, Evoked Response
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K221471 | 2022-11-22 |
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.