510(k) K021955 ยท DQA Oximeter
TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES OXIMETERS & ACCESSORIES
| Applicant | Datex-Ohmeda, Inc., Louisville CO, US |
| Decision | Substantially Equivalent, Oct 8, 2002 |
| Received | Jun 14, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K021955
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 7, 2023 | GE Healthcare Finland Oy TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-N; Oximeter Open, Classified |
DPZ | None listed |
| Jul 7, 2023 | GE Healthcare Finland Oy TruSignal Integrated Ear Sensor with Ohmeda Connector REF TS-E4-H; 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.