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)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| B155M | B155M Patient Monitor | Ge 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 ORT | 00195278490254 |
| B125M | B125M Patient Monitor | Ge 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 ORT | 00195278490247 |
| B105M | B105M Patient Monitor | Ge 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 ORT | 00195278490223 |
| B125P | B125P BT1 Patient Monitor | Ge 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 ORT | 00195278490230 |
| B105P | B105P Patient Monitor | Ge 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 ORT | 00195278488473 |