510(k) K230626 · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Portrait Central Viewer Application (Portrait CV A01), Portrait Core Services (Portrait CSS01), Portrait Clinical Alarming Unit (Portrait CAU01); Portrait Mobile Patient Monitor (Portrait HUB01), Portrait Sensor Battery (Portrait SBT01), Portrait Bedside Charger (Portrait BCH01); Portrait We
| Applicant | Ge Medical Systems Information Technologies, Inc., Wauwatosa WI, US |
| Decision | Substantially Equivalent, Aug 11, 2023 |
| Received | Mar 7, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230626
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 27, 2026 | GE Medical Systems Information Technologies Inc PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353 Open, Classified |
MWI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.