K243540
- 510(k) number
- K243540
- Device name
- 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. WI · US
- Product code
- DQK — Computer, Diagnostic, Programmable
- Decision date
- 2024-12-12
- Date received
- 2024-11-15
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K243540.pdf
Official FDA record: K243540
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.