510(k) K143676 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
B40i Patient Monitor
| Applicant | GE Healthcare Finland Oy, Helsinki, FI |
| Decision | Substantially Equivalent, Jul 31, 2015 |
| Received | Dec 24, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143676
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2018 | GE Healthcare, LLC B40i Patient Monitor and B40i Patient Monitor V3
The device is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters Open, Classified |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.