510(k) Report

Devices descending from K041772

18 later devices reach Datex-Ohmeda Prestn.01 Module (Model Family M-Prestn.01) and Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051217Datex-Ohmeda Prestin Module (Model Family E-Prestin, Including E-Prestin, E-Restin…GE Healthcare20061—
+1K043551Datex-Ohmeda S/5 PSM Module, (Consisting of E-PSM and E-PSMP Modules) and AccessoriesDatex-Ohmeda200515—
+2K062324Mri Monitor with L-CANE05 and L-CANE05A Software and Module Options N-Psngv, N-PSNG…GE Healthcare20060—
+2K062576Datex-Ohmeda S/5 E-PSM (P) Module (Consisting of E-PSM, E-PSMP and E-Intpsm Modules) and…GE Healthcare200614—
+3K120598Procare Monitor B40Ge Medical Systems China Co., Ltd.2012102
+3K093881Trusignal SPO2 Finger Sensor, Trusignal SPO2 Ear Sensor, Trusignal SPO2 Wrap SensorGE Healthcare Finland Oy20102Class I
+4K250931Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2…Unimed Medical Supplies, Inc.20250—
+4K132696Trusignal SPO2 Adult and Pediatric Adhesive Wrap Disposable SensorGE Healthcare Finland Oy20130—
+4K130584Monitor B40Ge Medical Systems China Co., Ltd.201382
+4K122253Procare Monitor B20Ge Medical Systems China Co., Ltd.201302
+5K133576Monitor B40Ge Medical Systems China Co., Ltd.20147Class I
+6K151063Monitor B40Ge Medical Systems China Co., Ltd.201551
+6K143676B40i Patient MonitorGE Healthcare Finland Oy201541
+7K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+7K171580Monitor B125, Monitor B105Ge Medical Systems (China) Co., Ltd.201741
+8K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+9K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+9K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401