510(k) K151063 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Monitor B40
| Applicant | Ge Medical Systems China Co., Ltd., Wuxi, CN |
| Decision | Substantially Equivalent, Dec 15, 2015 |
| Received | Apr 20, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K151063
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2018 | GE Healthcare, LLC PROCARE B40 Patient Monitor, V1; and B40 Patient Monitor, V2, V2.1, and V3.
The PROCARE Monitor B40 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarm Open, Classified |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.