510(k) K250897 ยท HFN Transducer, Pressure, Intrauterine
Koala Intrauterine Pressure Catheter (IPC-5000E)
| Applicant | Clinical Innovations, LLC, Murray UT, US |
| Decision | Substantially Equivalent, May 22, 2025 |
| Received | Mar 25, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250897
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.