510(k) K190008 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Carescape One
| Applicant | GE Healthcare, Milwaukee WI, US |
| Decision | Substantially Equivalent, Dec 20, 2019 |
| Received | Jan 2, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190008
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.