510(k) K043491 ยท GWE Stimulator, Photic, Evoked Response
ENFANTTM
| Applicant | Diopsys, Inc., Pine Brook NJ, US |
| Decision | Substantially Equivalent, Mar 16, 2005 |
| Received | Dec 17, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043491
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 26, 2010 | Diopsys, Inc. Diopsys Inc., Enfant Pediatric VEP Vision Testing System,
Input: 120 Vac, 60Hz/2.5A IEC 60601-1 Class I, Type BF. Terminated |
GWE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.