510(k) K100358 ยท HGM System, Monitoring, Perinatal
CENTRAL MONITORING SYSTEM
| Applicant | Edan Instruments, Inc., Yonkers NY, US |
| Decision | Substantially Equivalent, Jan 6, 2011 |
| Received | Feb 12, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100358
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.