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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
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.
3114 N Grandview Blvd.
Waukesha,  WI  53188
Applicant Contact James Turner
Correspondent
Ge Medical Systems Information Technologies, Inc.
3114 N Grandview Blvd.
Waukesha,  WI  53188
Correspondent Contact James Turner
Regulation Number870.1425
Classification Product Code
DQK  
Date Received11/15/2024
Decision Date 12/12/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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