510(k) Report

Devices descending from K043551

15 later devices reach Datex-Ohmeda S/5 PSM Module, (Consisting of E-PSM and E-PSMP Modules) and… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062576Datex-Ohmeda S/5 E-PSM (P) Module (Consisting of E-PSM, E-PSMP and E-Intpsm Modules) and…GE Healthcare200614—
+2K120598Procare Monitor B40Ge Medical Systems China Co., Ltd.2012102
+2K093881Trusignal SPO2 Finger Sensor, Trusignal SPO2 Ear Sensor, Trusignal SPO2 Wrap SensorGE Healthcare Finland Oy20102Class I
+3K250931Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2…Unimed Medical Supplies, Inc.20250—
+3K132696Trusignal SPO2 Adult and Pediatric Adhesive Wrap Disposable SensorGE Healthcare Finland Oy20130—
+3K130584Monitor B40Ge Medical Systems China Co., Ltd.201382
+3K122253Procare Monitor B20Ge Medical Systems China Co., Ltd.201302
+4K133576Monitor B40Ge Medical Systems China Co., Ltd.20147Class I
+5K151063Monitor B40Ge Medical Systems China Co., Ltd.201551
+5K143676B40i Patient MonitorGE Healthcare Finland Oy201541
+6K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+6K171580Monitor B125, Monitor B105Ge Medical Systems (China) Co., Ltd.201741
+7K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+8K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+8K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401