510(k) K880773 ยท GWL Amplifier, Physiological Signal
THE VENUS SYSTEM
| Applicant | Neuroscientific Corp., Farmingdale NY, US |
| Decision | Substantially Equivalent, Aug 18, 1988 |
| Received | Feb 26, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K880773
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 6, 2004 | Diopsys Inc The Enfant Evoked Response Photic Stimulator. The Enfant A Pediatric Vision Testing Device, Manufactured by Diopsys, Inc., 355 Main St., Metuchen, NJ 08840. Each medical device unit is assembled an Terminated |
GWE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.