510(k) K040831 ยท DPZ Oximeter, Ear
DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500
| Applicant | Datex-Ohmeda, Inc., Louisville CO, US |
| Decision | Substantially Equivalent, Sep 2, 2004 |
| Received | Mar 31, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040831
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 7, 2023 | GE Healthcare Finland Oy TruSignal Adult/Pediatric Sensor; Oximeter, Ear:
a) REF TS-AP-10, 10 pcs;
b) REF TS-AP-25, 25 pcs Open, Classified |
DPZ | None listed |
| Jul 7, 2023 | GE Healthcare Finland Oy TruSignal Integrated Ear Sensor with GE Connector REF TS-E2-GE; Oximeter, Ear Open, Classified |
DPZ | None listed |
| Jul 7, 2023 | GE Healthcare Finland Oy TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, physiological, patient(with arrhythmia detection or alarms) Open, Classified |
DPZ | None listed |
| Sep 14, 2011 | GE Healthcare, LLC DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500 (GE Healthcare) Terminated |
DPZ | None listed |
| Jun 22, 2010 | Ge Healthcare, Llc DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500 Terminated |
DPZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.