510(k) K010889 ยท HGM System, Monitoring, Perinatal
BABY DOPPLEX 3000 MK 2 (BD3000)
| Applicant | Huntleigh Healthcare, Inc., Cardiff, GB |
| Decision | Substantially Equivalent, Apr 25, 2001 |
| Received | Mar 26, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K010889
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.