510(k) K093881 ยท DQA Oximeter
TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP SENSOR
| Applicant | GE Healthcare Finland Oy, Helsinki, FI |
| Decision | Substantially Equivalent, Mar 12, 2010 |
| Received | Dec 18, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K093881
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 7, 2023 | GE Healthcare Finland Oy TruSignal AllFit Sensor:
a) REF TS-AF-10, 10 pcs;
B) REF AF-25, 25 pcs; Oximeter Open, Classified |
DPZ | None listed |
| Jul 7, 2023 | GE Healthcare Finland Oy TruSignal Sensitive Skin Sensor, REF TS-SE-3; Oximeter Open, Classified |
DPZ | None listed |
| Jul 7, 2023 | GE Healthcare Finland Oy TruSignal Wrap Sensor, REF TS-W-D; Oximeter Open, Classified |
DPZ | None listed |
| Jul 7, 2023 | GE Healthcare Finland Oy TruSignal Ear Sensor, REF TS-E-D; Oximeter Open, Classified |
DPZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.