510(k) K213490 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P
| Applicant | Ge Medical Systems Information Technologies, Inc., Wauwatosa WI, US |
| Decision | Substantially Equivalent, Apr 1, 2022 |
| Received | Nov 1, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213490
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 7, 2025 | GE Healthcare Finland Oy B105P, B125P, B105M, B125M, B155M Patient Monitors;
Model nos.
6160000-002
6160000-003
6160000-004
6160000-005
6160000-101
6160000-102
6160000-103
6160000-104
6160000-105
6160001-063
6160001-064
6160 Open, Classified |
MHX | None listed |
| Dec 19, 2022 | GE Medical Systems, LLC B105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX, Open, Classified |
MHX | None listed |
| Dec 19, 2022 | GE Medical Systems, LLC B125P Patient Monitor (with E-module slot option), REF 6160000-002 Open, Classified |
MHX | None listed |
| Dec 19, 2022 | GE Medical Systems, LLC B105M Patient Monitor, REF 6160000-003 Open, Classified |
MHX | None listed |
| Dec 19, 2022 | GE Medical Systems, LLC B125M Patient Monitor, REF 6160000-004-XXXXXX Open, Classified |
MHX | None listed |
| Dec 19, 2022 | GE Medical Systems, LLC B125M Patient Monitor, REF 6160000-005-XXXXXXX Open, Classified |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.