510(k) K080297 ยท FRN Pump, Infusion
MEDRAD INTEGO PET INFUSION SYSTEM
| Applicant | Medrad, Inc., Indianola PA, US |
| Decision | Substantially Equivalent, Jun 17, 2008 |
| Received | Feb 4, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080297
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 11, 2016 | Bayer Healthcare PET Infusion Pump Terminated |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.