510(k) Report

Devices descending from K983684

46 later devices reach Datex-Ohmeda 3800+/3800P+ or 3900/3900P Pulse Oximeters through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051367Patient Monitor, Models Dash 3000, 4000 and 5000Ge Medical Systems Information Technologies200591
+1K041522Flexi-Stat Disposable Adhesive SPO2 SensorsElekon Industries U.S.A., Inc.20042—
+1K041964Mediaid Reusable Finger Clip SPO2 Sensors and Disposable Non-Adhesive Sensors and…Mediaid, Inc.20040—
+1K041647Flexi-Stat Reusable Finger Clip SPO2 Sensors (Nellcor-Compatible),(Bci-Compatible)…Elekon Industries U.S.A., Inc.20042—
+1K041644Flexi-Stat Disposable Non-Adhesive SPO2 Sensors, (Nellcor-Compatible), (Bci-Compatible)…Elekon Industries U.S.A., Inc.20040—
+1K021955Trutrak Plus Enhancements to the Datex-Ohmeda 3800 Series & 3900 Series Oximeters &…Datex-Ohmeda, Inc.200228Class I
+2K093881Trusignal SPO2 Finger Sensor, Trusignal SPO2 Ear Sensor, Trusignal SPO2 Wrap SensorGE Healthcare Finland Oy20102Class I
+2K073462Modification to Dash 3000, 4000, 5000 Monitor and AccessoriesGe Medical Systems Information Technologies200889
+2K061191Finger and Ear Sensors and Neonatal-Adult and Adult/Pediatric Adhesive Sensors for Use…Measurement Specialties, Inc.20060—
+2K042705Disposable Non-Adhesive SPO2 SensorsElekon Industries U.S.A., Inc.20041—
+2K042704Reusable Finger Clip SPO2 SensorsElekon Industries U.S.A., Inc.20041—
+2K040831Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500Datex-Ohmeda, Inc.200427Class 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—
+3K083750Capnostat / Capnoflex CO2 SystemGe Medical Systems Information Technologies20090—
+3K080461Star ST and Arrhythmia Software, Release J.0Philips Medical Systems20086—
+3K073203Carescape V100Ge Medical Systems Information Technologies200720—
+3K042891Datex-Ohmeda Oxy-Afr SensorDatex-Ohmeda20050—
+3K050583Model 250 Series Maternal/Fetal MonitorGe Medical Systems Information Technologies20051—
+4K152305Nihon Kohden Afib Detection Program QP-039PNihon Kohden Corporation20160—
+4K120598Procare Monitor B40Ge Medical Systems China Co., Ltd.2012102
+4K102426Carescape Model V100 Vital Signs MonitorGe Medical Systems Information Technologies201011—
+4K101521ST/AR ST and Arrhythmia Software Model: Release K.OPhilips Medical Systems20104—
+4K072976Model 250CX Series Maternal/Fetal MonitorGE Healthcare20070—
+5K152659V10Mediana Co., Ltd.20162—
+5K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+5K151812Patient Monitors Various ModelsPhilips Medical Systems20160—
+5K151071SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20153—
+5K150082Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co., Ltd.201501
+5K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—
+5K133810VC150 Vital Signs MonitorInnokas Yhtyma201433
+5K130584Monitor B40Ge Medical Systems China Co., Ltd.201382
+5K122253Procare Monitor B20Ge Medical Systems China Co., Ltd.201302
+6K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+6K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+6K170497V10Mediana Co., Ltd.201711
+6K171751SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring…Capsule Technologie Sas20172—
+6K133576Monitor B40Ge Medical Systems China Co., Ltd.20147Class I
+7K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+7K200434V20, V20a, AVSM3 SNFMediana Co., Ltd.202001
+7K190468Nihon Kohden SVM-7200 Series Vital Signs MonitorNihon Kohden Corporation20190—
+7K180734SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie20180—
+7K151063Monitor B40Ge Medical Systems China Co., Ltd.201551
+7K143676B40i Patient MonitorGE Healthcare Finland Oy201541
+8K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+8K171580Monitor B125, Monitor B105Ge Medical Systems (China) Co., Ltd.201741