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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(k) Number K253277
Device Name Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P
Applicant
Ge Medical Systems Information Technologies, Inc.
9900 Innovation Dr.
Wauwatosa,  WI  53266
Applicant Contact Yanli Sun
Correspondent
Ge Medical Systems Information Technologies, Inc.
9900 Innovation Dr.
Wauwatosa,  WI  53266
Correspondent Contact Yanli Sun
Regulation Number870.1025
Classification Product Code
MHX  
Date Received09/29/2025
Decision Date 07/24/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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