510(k) K133407 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
GEM PREMIER 4000
| Applicant | Instrumentation Laboratory CO, Bedford MA, US |
| Decision | Substantially Equivalent, Jan 13, 2014 |
| Received | Nov 6, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K133407
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.