510(k) K964522 ยท FEN Device, Cystometric, Hydraulic
ELLIPSE 4
| Applicant | Andromeda Medizinische Systeme GmbH, Potomac MD, US |
| Decision | Substantially Equivalent, Mar 21, 1997 |
| Received | Nov 12, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964522
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.