510(k) Report

Devices descending from K032733

88 later devices reach PM-8000 Patient Monitor, Model 8000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K043348Modification to PM-8000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.200587—
+2K082887PM-1000F+Patient MonitorAdvanced Instrumentations, Inc.20090—
+2K063055VS-800 Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.200613—
+2K060281VS-800 Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.200616—
+2K053193PM-8000 Express Patient Monitor, Model PM-8000 ExpressShenzhen Mindray Bio-Medical Electronics Co., Ltd.200648—
+2K053234PM-9000 Express Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.2006711
+3K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc.20150—
+3K123711Patient MonitorShenzhen Creative Industry Co., Ltd.201313—
+3K112877Comen Multi-Parameter Patient MonitorGoldway (Us), Inc.20121—
+3K110922Patient MonitorEdan Instruments, Inc.201111
+3K100740MD2000B Vital Sign Monitor, Model MD2000BBeijing Choice Electronic Technololgy Co., Ltd.20102—
+3K101127Patient Monitor, Model PM50Contec Medical System Co., Ltd.20100—
+3K100394Multi-Parameter Patient Monitor, Model# PMS8210AShanghai 3f Electronics Co, Ltd.20101—
+3K082787Vital Signs Monitor, Model: MD500BBeijing Choice Electronic Technololgy Co., Ltd.20090—
+3K080173STAR 55Larsen & Toubro Limited20085—
+3K072235PM-50 Pulse Oximeter and VS-800 Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.200772
+3K070791PM Series Patient Monitors, Models PM-9000 Express and PM-8000 ExpressShenzhen Mindray Bio-Medical Electronics Co., Ltd.200747—
+4K211754Vital Signs MonitorBeijing Choice Electronic Technology Co., Ltd.20210—
+4K192343Patient MonitorShenzhen Creative Industry Co., Ltd.20190—
+4K173036North-vision Multi-parameter Patient MonitorNorth-Vision Tech., Inc.20180—
+4K172792Handheld Pulse Oximeter, Model SP-20Shenzhen Creative Industry Co., Ltd.20183—
+4K173454Multi-parameter Patient Monitor, models C30Shenzhen Comen Medical Instruments Co.,Ltd20180—
+4K172147STAR 65Skanray Technologies Pvt, Ltd.20180—
+4K170047All-in-One Health Monitor, PC-303Shenzhen Creative Industry Co., Ltd.20176—
+4K132037Vital Signs MonitorMindray North America201432
+4K132038Accutorr 7 Vital Signs MonitorMindray North America20142—
+4K130056Patient MonitorLd Technology, LLC20130—
+4K120631Patient MonitorAdvanced Instruments, Inc.20120—
+4K113183PMS8210A (Iris) Multi-Parameter Patient Monitor, Model Code 500Shanghai 3f Electronics Co, Ltd.20120—
+4K103686STAR 50 NLarsen & Toubro Limited20111—
+4K091834Passport V Monitor, Model 0998-00-6100Datascope Corp., Patient Monitoring Division200902
+4K090172Star 55 Model 100Larsen & Toubro Limited20090—
+4K082685Galaxy 55Larsen & Toubro Limited20080—
+4K073280Beneview T Series Patient Monitors, Models T8, T6 and T5Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20082—
+4K072581PM-60 Pulse OximeterShenzhen Mindray Bio-Medical Electronics Co., Ltd.200819—
+4K072346PM-7000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.200719—
+5K253436c-med0 alphaCosinuss GmbH20260—
+5K231625VitalDetectWellvii, Inc.20240—
+5K221113Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.20220—
+5K210086Vitals360 Multi-Vitals Mobile MonitorVocare, Inc.20214—
+5K202892Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3sEdan Instruments, Inc.202111
+5K201468Pulse OximeterShenzhen Creative Industry Co., Ltd.20212—
+5K170712Accutorr 7/VS-900 Vital Signs MonitorShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201711
+5K132033BM3/BM3 PlusNoblitt & Rueland20130—
+5K101692Patient MonitorContec Medical System Co., Ltd.201101
+5K100046M Seires Patient Monitor Model M66, M69, M8000, M9000, M7000Guangdong Biolight Meditech Co., Ltd.201016—
+5K092970General Patient Monitors, Models: G3C/ G3D/ G3F/ G3G/ G3HGeneral Meditech, Inc.20100—
+5K092727H100B Pulse OximeterEdan Instruments, Inc.20090—
+5K090599MD300K1 Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20099—
+5K090671Pulse Oximeter, Models CMS50E, CMS50F, CMS60C, CMS60DContec Medical System Co., Ltd.20093—
+5K081712Fingertip Pulse Oximeter, Model M70, and Handheld Pulse Oximeter, Model M700Guangdong Biolight Meditech Co., Ltd.20083—
+6K231116Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd.20240—
+6K233038Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3sEdan Instruments, Inc.202401
+6K222330The Heart SeatCasana Care, Inc.20230—
+6K213431Handheld Pulse OximeterShenzhen Witleaf Medical Electronics Co., Ltd.20230—
+6K212975MedWandMedwand Solutions, Inc.20221—
+6K212300Pulse OximeterShenzhen Mericonn Technology Co., Ltd.20220—
+6K182821Accutorr 7/VS-900/VS-900c Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.201901
+6K152563Pulse Oximeter (MD300M/MD300K2)Beijing Choice Electronic Technology Co., Ltd.20168—
+6K151287Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70DGuangdong Biolight Meditech Co., Ltd.20160—
+6K141362Pulse Oximeter CMS50EWContec Medical Systems Co.,Ltd20151—
+6K131762Handheld MonitorGuangdong Biolight Meditech Co., Ltd.20147—
+6K131876M Series Patient MonitorMid-Link Consulting Co, Ltd.20140—
+6K131763Truscope Series Patient MonitorGuangdong Biolight Meditech Co., Ltd.20130—
+6K113833Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20123—
+6K112804Fingertip Pulse OximeterGuangdong Biolight Meditech Co., Ltd.20120—
+6K112803Patient MonitorGuangdong Biolight Meditech Co., Ltd.20110—
+6K102040Patient MonitorGuangdong Biolight Meditech Co., Ltd.20101—
+6K101694Handheld Pulse Oximeter Model M800Guangdong Biolight Meditech Co., Ltd.20100—
+7K232111NeoBeat, NeoBeat MiniLaerdal Medical AS20240—
+7K172141Pulse OximeterShanghai Berry Electronic Tech Co., Ltd.20180—
+7K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+7K153135Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20162—
+7K150869Checkme Pro Health MonitorViatom Technology Co., Ltd.20155—
+8K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+8K230415Cadwell GuardianCadwell Industries, Inc.20230—
+8K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+8K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health)20210—
+8K191088Checkme O2 Pulse OximeterShenzhen Viatom Technology Co., Ltd.20192—
+8K190090DynoSense Vital Sign Measuring SystemDynosense Corp.20190—
+8K181919Patient MonitorGuangdong Biolight Meditech Co., Ltd.20190—
+8K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+8K170538RVS-100 Vital Signs MonitorRudolf Riester GmbH20170—
+9K242876Pulse Oximeter ( PO2, PO2A, PO2B)Shenzhen Viatom Technology Co., Ltd.20250—
+9K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+9K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+9K213515WesperO2Wesper, Inc.20220—
+10K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302