510(k) K964414 ยท LMC Camera, Multi Format, Radiological
LR 5200 LASER FILM RECORDER
| Applicant | Bayer Corp., Agfa Div., Ridgefield Park NJ, US |
| Decision | Substantially Equivalent, Jan 27, 1997 |
| Received | Nov 5, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964414
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 11, 2003 | AGFA Corp. SCOPIX LR 5200P Laser Imagers, Type 8394/600, serial numbers between 4000 and 5266. Terminated |
LMC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.