510(k) K233810 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Portrait VSM
| Applicant | Ge Medical Systems Information Technologies, Inc., Wauwatosa WI, US |
| Decision | Substantially Equivalent, Apr 25, 2024 |
| Received | Nov 30, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233810
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 7, 2025 | GE Healthcare Finland Oy Portrait VSM
Model nos.
6660000-666
Monitor, Physiological, Patient (With
Arrhythmia Detection or Alarms Open, Classified |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.