Stimulator, Photic, Evoked Response
Diopsys Inc.'s record for this product code
MDR events0All time
Recalls2All time
510(k) clearances2All time
Recent MDR events
0 adverse event reports on file
No MDR events on file for Diopsys Inc. under this product code.
Recalls
2 recall events for this product code
- TerminatedApr 26, 2010
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 2007.
View FDA record ↗ - TerminatedNov 6, 2004
The firm established no medical device quality system, no established quality plan and no established quality procedures.
View FDA record ↗
510(k) clearances
2 clearances for this product code