510(k) K964279 ยท KXO Monitor, Pressure, Intrauterine
SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC)
| Applicant | Graphic Controls Corp., Buafflo NY, US |
| Decision | Substantially Equivalent, Jan 22, 1997 |
| Received | Oct 28, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964279
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.