510(k) Report

Devices descending from K962127

42 later devices reach Ohmeda 3800 Pulse Oximeter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103584Envisen Nellcor, Bci, Nonin, Csi, HP/Philips, Datex-Ohmeda Compatible Disposable and…Shenzhen Envisen Industry Co. Limited20110—
+1K061931Solaris Compatible Reusable Adult SPO2 Finger Sensors, Models S100A-090103 and 300103…Solaris Medical Technology, Inc.20070—
+1K043463Envitec Reusable Multi-Site Y SPO2 SensorsEnvitec-Wismar GmbH20055—
+1K021955Trutrak Plus Enhancements to the Datex-Ohmeda 3800 Series & 3900 Series Oximeters &…Datex-Ohmeda, Inc.200228Class I
+1K981655Spacelabs Medical Disposable SP02 SensorSpacelabs Medical, Inc.19990—
+1K982728Nellcor Puritan Bennett Uniprobe Adapter Cable, UP12A, UP12B, UP12CNellcor Puritan Bennett, Inc.19980—
+1K972468NPB-195 Pulse OximeterNellcor Puritan Bennett, Inc.19976—
+2K093881Trusignal SPO2 Finger Sensor, Trusignal SPO2 Ear Sensor, Trusignal SPO2 Wrap SensorGE Healthcare Finland Oy20102Class I
+2K060675Envitec Reusable Softip Y SPO2 SensorsEnvitec-Wismar GmbH20064—
+2K040831Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500Datex-Ohmeda, Inc.200427Class I
+2K041548Sentec Digital Monitor Model #SDMSentec, Inc.200459
+3K250931Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2…Unimed Medical Supplies, Inc.20250—
+3K232516Sentec Digital Monitoring System (SDMS) tCOM+Sentec AG20240—
+3K132696Trusignal SPO2 Adult and Pediatric Adhesive Wrap Disposable SensorGE Healthcare Finland Oy20130—
+3K101690Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor Adaper CableSentec AG2010312
+3K073203Carescape V100Ge Medical Systems Information Technologies200720—
+3K071672Sentec Digital Monitoring SystemSentec AG200741
+3K042891Datex-Ohmeda Oxy-Afr SensorDatex-Ohmeda20050—
+3K050583Model 250 Series Maternal/Fetal MonitorGe Medical Systems Information Technologies20051—
+4K162014Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2…Bluepoint Medical GmbH & Co. KG20170—
+4K151329SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC…Sentec AG201519
+4K120598Procare Monitor B40Ge Medical Systems China Co., Ltd.2012102
+4K102426Carescape Model V100 Vital Signs MonitorGe Medical Systems Information Technologies201011—
+4K072976Model 250CX Series Maternal/Fetal MonitorGE Healthcare20070—
+5K152659V10Mediana Co., Ltd.20162—
+5K151071SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20153—
+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