510(k) Report

Devices descending from K021955

28 later devices reach Trutrak Plus Enhancements to the Datex-Ohmeda 3800 Series & 3900 Series… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093881Trusignal SPO2 Finger Sensor, Trusignal SPO2 Ear Sensor, Trusignal SPO2 Wrap SensorGE Healthcare Finland Oy20102Class I
+1K040831Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500Datex-Ohmeda, Inc.200427Class I
+2K250931Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2…Unimed Medical Supplies, Inc.20250—
+2K132696Trusignal SPO2 Adult and Pediatric Adhesive Wrap Disposable SensorGE Healthcare Finland Oy20130—
+2K073203Carescape V100Ge Medical Systems Information Technologies200720—
+2K042891Datex-Ohmeda Oxy-Afr SensorDatex-Ohmeda20050—
+2K050583Model 250 Series Maternal/Fetal MonitorGe Medical Systems Information Technologies20051—
+3K120598Procare Monitor B40Ge Medical Systems China Co., Ltd.2012102
+3K102426Carescape Model V100 Vital Signs MonitorGe Medical Systems Information Technologies201011—
+3K072976Model 250CX Series Maternal/Fetal MonitorGE Healthcare20070—
+4K152659V10Mediana Co., Ltd.20162—
+4K151071SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20153—
+4K133810VC150 Vital Signs MonitorInnokas Yhtyma201433
+4K130584Monitor B40Ge Medical Systems China Co., Ltd.201382
+4K122253Procare Monitor B20Ge Medical Systems China Co., Ltd.201302
+5K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+5K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+5K170497V10Mediana Co., Ltd.201711
+5K171751SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring…Capsule Technologie Sas20172—
+5K133576Monitor B40Ge Medical Systems China Co., Ltd.20147Class I
+6K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+6K200434V20, V20a, AVSM3 SNFMediana Co., Ltd.202001
+6K190468Nihon Kohden SVM-7200 Series Vital Signs MonitorNihon Kohden Corporation20190—
+6K180734SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie20180—
+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