510(k) Report

Devices descending from K213972

1 later device reach Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243540Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client…Ge Medical Systems Information Technologies, Inc.20240—