510(k) K243540
Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i) by
Ge Medical Systems Information Technologies, Inc.
— Product Code DQK
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 12, 2024
- Date Received
- November 15, 2024
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computer, Diagnostic, Programmable
- Device Class
- Class II
- Regulation Number
- 870.1425
- Review Panel
- CV
- Submission Type