510(k) K050423 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
OMNI MODULAR, OMNI C AND OMNI S ANALYZER (PH ELECTRODE)
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Apr 22, 2005 |
| Received | Feb 18, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050423
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.