510(k) K223608 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
GEM Premier 7000 with IQM3
| Applicant | Instrumentation Laboratory Company, Bedford MA, US |
| Decision | Substantially Equivalent, Aug 10, 2023 |
| Received | Dec 2, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223608
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 6, 2026 | Instrumentation Laboratory GEM Premier 7000 with iQM3
Part Numbers:
00077407508
00077407510
00077415004
00077415008
00077415010
00077430010
Product Description: The GEM Premier 7000 with iQM3 is a portable critical care sys Open, Classified |
CHL | None listed |
| Jul 29, 2026 | Instrumentation Laboratory Brand Name: GEM Premier 7000 with iQM3
Product Name: GEM Premier 7000 with iQM3
Model/Catalog Number: 00000015279
Intelligent Quality Management 3 (iQM3) is used as the quality control (QC) and asses Open, Classified |
CHL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.