510(k) Report

Devices descending from K043348

87 later devices reach Modification to PM-8000 Patient Monitor through their predicates, nearest generation first.

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