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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K253277

Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P · Ge Medical Systems Information Technologies, Inc. · decided 2026-07-24 (SESE)

FDA 510(k) database ↗

Devices

BrandModelCompanyProduct codesPrimary DI
B155MB155M Patient MonitorGe Medical Systems Information Technologies, Inc.BZQ CBQ CBR CBS CCK CCL DPZ DQA DQK DRT DSI DSJ DSK DXN FLL GWQ KOI KRB MHX MLD NHO NHP NHQ OLT OLW OMC ORT00195278490254
B125MB125M Patient MonitorGe Medical Systems Information Technologies, Inc.BZQ CBQ CBR CBS CCK CCL DPZ DQA DQK DRT DSI DSJ DSK DXN FLL GWO KOI KRB MHX MLD NHO NHP NHQ OLT OLW OMC ORT00195278490247
B105MB105M Patient MonitorGe Medical Systems Information Technologies, Inc.BZQ CBQ CBR CBS CCK CCL DPZ DQA DQK DRT DSI DSJ DSK DXN FLL GWQ KOI KRB MHX MLD NHO NHP NHQ OLT OLW OMC ORT00195278490223
B125PB125P BT1 Patient MonitorGe Medical Systems Information Technologies, Inc.BZQ CBQ CBR CBS CCK CCL DPZ DQA DQK DRT DSI DSJ DSK DXN FLL GWO KOI KRB MHX MLD NHO NHP NHQ OLT OLW OMC ORT00195278490230
B105PB105P Patient MonitorGe Medical Systems Information Technologies, Inc.BZQ CBQ CBR CBS CCK CCL DPZ DQA DQK DRT DSI DSJ DSK DXN FLL GWO KOI KRB MHX MLD NHO NHP NHQ OLT OLW OMC ORT00195278488473