510(k) K243540 ยท DQK Computer, Diagnostic, Programmable
Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)
| Applicant | Ge Medical Systems Information Technologies, Inc., Waukesha WI, US |
| Decision | Substantially Equivalent, Dec 12, 2024 |
| Received | Nov 15, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K243540
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.