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Stimulator, Photic, Evoked Response
FDA product code GWE · Class 2 · Neurology
405
Registered devices
11
Adverse events
3
Recalls
49
510(k) clearances
Devices with this code
NA — MEDTRONIC XOMED, INC.UTAS — L K C TECHNOLOGIES, INC.Sierra Summit — CADWELL INDUSTRIES, INC.Diopsys® — DIOPSYS, INC.Micromed — MICROMED SPANA — MEDTRONIC XOMED, INC.Cascade Elite — CADWELL INDUSTRIES, INC.IOMAX Extender Pod — CADWELL INDUSTRIES, INC.Sierra Summit — CADWELL INDUSTRIES, INC.Sierra Wave — CADWELL INDUSTRIES, INC.Espion — DIAGNOSYS LLCUTAS — L K C TECHNOLOGIES, INC.NIM-ECLIPSE® — MEDTRONIC XOMED, INC.UTAS — L K C TECHNOLOGIES, INC.RETI-port/scan 21 beta — Roland Consult Stasche & Finger GmbHmicromed — MICROMED SPARETeval™ — L K C TECHNOLOGIES, INC.NA — MEDTRONIC XOMED, INC.Standalone — DIAGNOSYS LLCEspion — DIAGNOSYS LLCEspion — DIAGNOSYS LLCMicromed — MICROMED SPAColorDome Desktop Ganzfeld Stimulator — DIAGNOSYS LLCN/A — MEDTRONIC SOFAMOR DANEK, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-01-02 | Natus Medical Incorporated | Software error occurs when using remote monitoring; if the remote user tries to stop the free run waveform group, the system will display a message informing th |
| 2007-04-02 | Diopsys, Inc. | The computer based system may lose test counts when the time in the device was changed during a changeover from standard time to daylight savings time in March |
| 2004-09-15 | Diopsys Inc | The firm established no medical device quality system, no established quality plan and no established quality procedures. |
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