510(k) K100797 ยท HGM System, Monitoring, Perinatal
FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS
| Applicant | Edan Instruments, Inc., Great Neck NY, US |
| Decision | Substantially Equivalent, Nov 10, 2010 |
| Received | Mar 22, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100797
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.