510(k) K082369 ยท HGM System, Monitoring, Perinatal
CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR
| Applicant | Edan Instruments, Inc., Yonkers NY, US |
| Decision | Substantially Equivalent, Nov 7, 2008 |
| Received | Aug 18, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K082369
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.