510(k) K160412 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)
| Applicant | Instrumentation Laboratory CO, Bedford MA, US |
| Decision | Substantially Equivalent, Dec 14, 2016 |
| Received | Feb 12, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160412
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 10, 2026 | Instrumentation Laboratory GEM Premier 5000; Part No. 00055415010. Open, Classified |
CHL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.