510(k) Report

Devices descending from K043276

11 later devices reach Datex-Ohmeda S/5TM FM with L-FICU04 and L-FICU04A Software and N-Fcrec Module through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120598Procare Monitor B40Ge Medical Systems China Co., Ltd.2012102
+2K130584Monitor B40Ge Medical Systems China Co., Ltd.201382
+2K122253Procare Monitor B20Ge Medical Systems China Co., Ltd.201302
+3K133576Monitor B40Ge Medical Systems China Co., Ltd.20147Class I
+4K151063Monitor B40Ge Medical Systems China Co., Ltd.201551
+4K143676B40i Patient MonitorGE Healthcare Finland Oy201541
+5K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+5K171580Monitor B125, Monitor B105Ge Medical Systems (China) Co., Ltd.201741
+6K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+7K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+7K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401