510(k) K211619 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Multi-Parameter Patient Monitor
| Applicant | Shenzhen Comen Medical Instruments Co.,Ltd, Shenzhen, CN |
| Decision | Substantially Equivalent, Dec 29, 2022 |
| Received | May 26, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211619
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.