510(k) K130584 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
MONITOR B40
| Applicant | Ge Medical Systems China Co., Ltd., Milwaukee WI, US |
| Decision | Substantially Equivalent, Jun 26, 2013 |
| Received | Mar 5, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130584
| 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 |
| Dec 12, 2013 | GE Healthcare, LLC HGE Healthcare Patient Monitor B30, Procare Monitor B20, Procare Monitor B40, and Monitor B40
K122253 (Procare Monitor B20): The PROCARE Monitor B20 is a portable multiparameter unit to be used for mo Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.