510(k) K001677 ยท HGM System, Monitoring, Perinatal
BABY DOPPLEX 4000 (BD4000)
| Applicant | Huntleigh Diagnostics , Ltd., Cardiff Wales, GB |
| Decision | Substantially Equivalent, Aug 14, 2000 |
| Received | Jun 1, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K001677
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.