510(k) K173403 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
GEM Premier 5000
| Applicant | Instrumentation Laboratory CO, Bedford MA, US |
| Decision | Substantially Equivalent, Dec 29, 2017 |
| Received | Oct 31, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173403
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.