510(k) K002548 ยท HGM System, Monitoring, Perinatal
FETAL ASSIST
| Applicant | Huntleigh Diagnostics , Ltd., Cardiff Wales, GB |
| Decision | Substantially Equivalent, Mar 6, 2001 |
| Received | Aug 17, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002548
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.