510(k) K133576 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, Feb 21, 2014 |
| Received | Nov 20, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K133576
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 10, 2020 | GE Healthcare, LLC Airway Gas Option N-CAiO Terminated |
CCK | None listed |
| 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 |
| Sep 9, 2014 | GE Healthcare, LLC CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE; the Airway Gas Option N-CAiO and respective service exchange units.
The affected modules could be in use with any Terminated |
CCL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.