510(k) K153580 ยท HGM System, Monitoring, Perinatal
Central Monitoring System
| Applicant | Guangdong Biolight Meditech Co., Ltd., Zhuhai, CN |
| Decision | Substantially Equivalent, Sep 7, 2016 |
| Received | Dec 15, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153580
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.