510(k) K213972 ยท DQK Computer, Diagnostic, Programmable
Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX
| Applicant | Ge Healthcare Information Technologies, Inc., Wauwatosa WI, US |
| Decision | Substantially Equivalent, Feb 17, 2022 |
| Received | Dec 20, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213972
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 19, 2023 | GE Medical Systems Information Technologies Inc Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CardioLab AltiX and ComboLab AltiX. Open, Classified |
DQK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.