510(k) K961290 ยท KXO Monitor, Pressure, Intrauterine
IUP - TIP TRANS, IUP - PROXI TRANS
| Applicant | Scientific Device Manufacturer, LLC, San Rafael CA, US |
| Decision | Substantially Equivalent, Oct 15, 1996 |
| Received | Apr 4, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961290
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.