510(k) K974389 ยท HFN Transducer, Pressure, Intrauterine
KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHETER
| Applicant | Clinical Innovations, Inc., Murray UT, US |
| Decision | Substantially Equivalent, Feb 19, 1998 |
| Received | Nov 21, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974389
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.