510(k) K963711 ยท HGM System, Monitoring, Perinatal
BABY DOPPLEX (3000)
| Applicant | Huntleigh Healthcare, Inc., Manalapan NJ, US |
| Decision | Substantially Equivalent, Sep 12, 1997 |
| Received | Sep 16, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963711
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.