510(k) K040903 ยท HGM System, Monitoring, Perinatal
CADENCE, MODELS 2001 AND 2002
| Applicant | Edan Instruments, Inc., Yonkers NY, US |
| Decision | Substantially Equivalent, Sep 2, 2004 |
| Received | Apr 7, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040903
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.