510(k) Report

Devices descending from K913695

199 later devices reach Nellcor (R) N-180 Pulse Oximeter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K182821Accutorr 7/VS-900/VS-900c Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.201901
+7K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+7K162607BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2017121
+7K161517Mortara Surveyor Patient MonitorMortara Instrument, Inc.20171—
+7K152659V10Mediana Co., Ltd.20162—
+7K152043Diagnostic Station DS20Schiller AG20161—
+7K152563Pulse Oximeter (MD300M/MD300K2)Beijing Choice Electronic Technology Co., Ltd.20168—
+7K153079Axeo 3 Patient MonitorAxeo Medical Technologies, LLC20160—
+7K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+7K151287Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70DGuangdong Biolight Meditech Co., Ltd.20160—
+7K150329elance Vital Signs Monitor, Central Monitor SoftwareSpacelabs Healthcare20150—
+7K151071SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20153—
+7K150620740 SelectCas Medical Systems, Inc.201501
+7K141362Pulse Oximeter CMS50EWContec Medical Systems Co.,Ltd20151—
+7K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc.20150—
+7K142244Cleo Patient MonitorInfinium Medical201501
+7K133810VC150 Vital Signs MonitorInnokas Yhtyma201433
+7K131762Handheld MonitorGuangdong Biolight Meditech Co., Ltd.20147—
+7K131876M Series Patient MonitorMid-Link Consulting Co, Ltd.20140—
+7K132026V Series Monitoring System, 12.1 Dcu/V12 and 21.0 Dcu/V21Mindray DS USA, Inc.201321
+7K123711Patient MonitorShenzhen Creative Industry Co., Ltd.201313—
+7K131763Truscope Series Patient MonitorGuangdong Biolight Meditech Co., Ltd.20130—
+7K130584Monitor B40Ge Medical Systems China Co., Ltd.201382
+7K122253Procare Monitor B20Ge Medical Systems China Co., Ltd.201302
+7K120631Patient MonitorAdvanced Instruments, Inc.20120—
+7K113833Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20123—
+7K112804Fingertip Pulse OximeterGuangdong Biolight Meditech Co., Ltd.20120—
+7K112803Patient MonitorGuangdong Biolight Meditech Co., Ltd.20110—
+7K102040Patient MonitorGuangdong Biolight Meditech Co., Ltd.20101—
+7K101694Handheld Pulse Oximeter Model M800Guangdong Biolight Meditech Co., Ltd.20100—
+7K100394Multi-Parameter Patient Monitor, Model# PMS8210AShanghai 3f Electronics Co, Ltd.20101—
+7K080173STAR 55Larsen & Toubro Limited20085—
+8K232111NeoBeat, NeoBeat MiniLaerdal Medical AS20240—
+8K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+8K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+8K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+8K192343Patient MonitorShenzhen Creative Industry Co., Ltd.20190—
+8K183238BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201911—
+8K173036North-vision Multi-parameter Patient MonitorNorth-Vision Tech., Inc.20180—
+8K172792Handheld Pulse Oximeter, Model SP-20Shenzhen Creative Industry Co., Ltd.20183—
+8K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+8K172147STAR 65Skanray Technologies Pvt, Ltd.20180—
+8K172141Pulse OximeterShanghai Berry Electronic Tech Co., Ltd.20180—
+8K170497V10Mediana Co., Ltd.201711
+8K171751SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring…Capsule Technologie Sas20172—
+8K170047All-in-One Health Monitor, PC-303Shenzhen Creative Industry Co., Ltd.20176—
+8K170182Cardiovit FT-1Schiller AG20170—
+8K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+8K153135Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20162—
+8K150869Checkme Pro Health MonitorViatom Technology Co., Ltd.20155—
+8K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—
+8K133576Monitor B40Ge Medical Systems China Co., Ltd.20147Class I
+8K113183PMS8210A (Iris) Multi-Parameter Patient Monitor, Model Code 500Shanghai 3f Electronics Co, Ltd.20120—
+8K103686STAR 50 NLarsen & Toubro Limited20111—
+8K090172Star 55 Model 100Larsen & Toubro Limited20090—
+8K082685Galaxy 55Larsen & Toubro Limited20080—
+9K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+9K253436c-med0 alphaCosinuss GmbH20260—
+9K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+9K231625VitalDetectWellvii, Inc.20240—
+9K230415Cadwell GuardianCadwell Industries, Inc.20230—
+9K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+9K210086Vitals360 Multi-Vitals Mobile MonitorVocare, Inc.20214—
+9K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health)20210—
+9K201468Pulse OximeterShenzhen Creative Industry Co., Ltd.20212—
+9K200434V20, V20a, AVSM3 SNFMediana Co., Ltd.202001
+9K193391BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2020102
+9K191088Checkme O2 Pulse OximeterShenzhen Viatom Technology Co., Ltd.20192—
+9K190090DynoSense Vital Sign Measuring SystemDynosense Corp.20190—
+9K190468Nihon Kohden SVM-7200 Series Vital Signs MonitorNihon Kohden Corporation20190—
+9K181919Patient MonitorGuangdong Biolight Meditech Co., Ltd.20190—
+9K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+9K180734SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie20180—
+9K170538RVS-100 Vital Signs MonitorRudolf Riester GmbH20170—
+9K151063Monitor B40Ge Medical Systems China Co., Ltd.201551
+9K143676B40i Patient MonitorGE Healthcare Finland Oy201541
+9K132033BM3/BM3 PlusNoblitt & Rueland20130—
+10K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.20260—
+10K242876Pulse Oximeter ( PO2, PO2A, PO2B)Shenzhen Viatom Technology Co., Ltd.20250—
+10K231116Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd.20240—
+10K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+10K231477Infinity CentralStation Wide, Infinity M300, Infinity M300+Draeger Medical Systems, Inc.20231—
+10K223567CNS-2101 Central MonitorNihon Kohden Corporation20232—
+10K222330The Heart SeatCasana Care, Inc.20230—
+10K213431Handheld Pulse OximeterShenzhen Witleaf Medical Electronics Co., Ltd.20230—
+10K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+10K212975MedWandMedwand Solutions, Inc.20221—
+10K213515WesperO2Wesper, Inc.20220—
+10K220058BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202231
+10K212300Pulse OximeterShenzhen Mericonn Technology Co., Ltd.20220—
+10K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+10K171580Monitor B125, Monitor B105Ge Medical Systems (China) Co., Ltd.201741
+11K242728BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202502
+11K242750Central StationNihon Kohden Digital Health Solutions, LLC20251—
+11K240312Infinity CentralStation WideDraeger Medical Systems, Inc.20240—
+11K232694Central Monitoring System (MFM-CMS)Edan Instruments, Inc.202411
+11K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+12K260211Dashboard (P007000)Hill-Rom, Inc.20260—
+12K250349Vista CMSShanghai Draeger Medical Instrument Co., Ltd.20260—