510(k) K123335 ยท HGM System, Monitoring, Perinatal
SUNRAY FETAL MONITOR
| Applicant | Sunray Medical Apparatus Co., Ltd., Shenzhen, Guangdong, CN |
| Decision | Substantially Equivalent, Mar 21, 2013 |
| Received | Oct 26, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123335
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.