Device Listing 1816403130

Listing Summary#

Listing key
1816403130
Premarket submission
K243540
Device
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.
Product code
DQK
Decision date
2024-12-12