510(k) K143695 ยท HGM System, Monitoring, Perinatal
CENTRAL MONITORING SYSTEM
| Applicant | Edan Instruments, Inc., Shenzhen, CN |
| Decision | Substantially Equivalent, Mar 30, 2015 |
| Received | Dec 24, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143695
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.