510(k) K191106 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
C50 and C80 Multi-parameter Patient Monitor
| Applicant | Shenzhen Comen Medical Instruments Co.,Ltd, Shenzhen, CN |
| Decision | Substantially Equivalent, Dec 13, 2019 |
| Received | Apr 25, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191106
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.