510(k) K042675 ยท DPZ Oximeter, Ear
FLEXI-STAT SP02 EAR SENSOR
| Applicant | Elekon Industries U.S.A., Inc., Plano TX, US |
| Decision | Substantially Equivalent, Dec 6, 2004 |
| Received | Sep 29, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042675
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.