510(k) K191149 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
CARESCAPE B650
| Applicant | GE Healthcare Finland Oy, Helsinki, FI |
| Decision | Substantially Equivalent, Jan 21, 2020 |
| Received | Apr 30, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191149
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 21, 2024 | GE Healthcare Finland Oy CARESCAPE B650: Model Numbers:
a) MBB313, Model Numbers:
1) 2095801-001,
2) 2095801-001-01018416,
3) 2095801-001-01023150,
4) 2095801-001-01023151,
5) 2095801-001-01023152,
6) 2095801-001-01 Open, Classified |
MHX | None listed |
| Jun 21, 2024 | GE Healthcare Finland Oy CARESCAPE B850 Model Numbers:
a) MBC303, Model Numbers:
1) 2078633-001,
2) 2078633-010,
3) 2078633-012,
4) 2078633-017,
5) 2078633-028,
6) 2095802-001-54069330,
7) 2095802-001-554922,
8) 2 Open, Classified |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.