510(k) K041647 ยท DQA Oximeter
FLEXI-STAT REUSABLE FINGER CLIP SPO2 SENSORS (NELLCOR-COMPATIBLE),(BCI-COMPATIBLE), (DATEX-COMPATIBLE)
| Applicant | Elekon Industries U.S.A., Inc., Plano TX, US |
| Decision | Substantially Equivalent, Sep 2, 2004 |
| Received | Jun 17, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041647
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.