510(k) Report

Devices descending from K020550

75 later devices reach Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101619Welch Allyn 1500 Patient MonitorSchiller AG20104—
+1K090443Planet 55, Model 100Larsen & Toubro Limited20090—
+1K070791PM Series Patient Monitors, Models PM-9000 Express and PM-8000 ExpressShenzhen Mindray Bio-Medical Electronics Co., Ltd.200747—
+1K062144Escort M8 Vital Signs Patient Monitor, Model 3810Invivo Corporation200611—
+1K031849Spectrum Patient Monitor, Model 0998-00-0500-XxxxxDatascope Corp.200391
+2K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd.20143—
+2K112877Comen Multi-Parameter Patient MonitorGoldway (Us), Inc.20121—
+2K091834Passport V Monitor, Model 0998-00-6100Datascope Corp., Patient Monitoring Division200902
+2K090556Spacelabs Elance Vital Signs Monitoring System and Central Monitor SoftwareSpacelabs Healthcare Medical Equipment (Suzhou) CO2009101
+2K082887PM-1000F+Patient MonitorAdvanced Instrumentations, Inc.20090—
+2K073280Beneview T Series Patient Monitors, Models T8, T6 and T5Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20082—
+2K072581PM-60 Pulse OximeterShenzhen Mindray Bio-Medical Electronics Co., Ltd.200819—
+2K072346PM-7000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.200719—
+2K062098Spectrum Monitor, Model 0998-00-1000-XxxxxDatascope Corp.20077—
+3K173454Multi-parameter Patient Monitor, models C30Shenzhen Comen Medical Instruments Co.,Ltd20180—
+3K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+3K132229Omni Patent MonitorsInfinium Medical20142—
+3K130740Nightingale Monitoring SystemZoe Medical, Inc.20133—
+3K123556Mortara Surveyor Patient MonitorMortara Instrument, Inc.201321
+3K110922Patient MonitorEdan Instruments, Inc.201111
+3K101692Patient MonitorContec Medical System Co., Ltd.201101
+3K102004Endeavour Monitoring SystemMindray DS USA, Inc.201033
+3K093802Ultraview DM3 MonitorZoe Medical, Inc.201002
+3K100046M Seires Patient Monitor Model M66, M69, M8000, M9000, M7000Guangdong Biolight Meditech Co., Ltd.201016—
+3K092970General Patient Monitors, Models: G3C/ G3D/ G3F/ G3G/ G3HGeneral Meditech, Inc.20100—
+3K092727H100B Pulse OximeterEdan Instruments, Inc.20090—
+3K093501Elance Vital Signs Monitor and Elance Central StationSpacelabs Medical, Inc.200912
+3K090599MD300K1 Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20099—
+3K090671Pulse Oximeter, Models CMS50E, CMS50F, CMS60C, CMS60DContec Medical System Co., Ltd.20093—
+3K081712Fingertip Pulse Oximeter, Model M70, and Handheld Pulse Oximeter, Model M700Guangdong Biolight Meditech Co., Ltd.20083—
+4K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+4K161517Mortara Surveyor Patient MonitorMortara Instrument, Inc.20171—
+4K152043Diagnostic Station DS20Schiller AG20161—
+4K152563Pulse Oximeter (MD300M/MD300K2)Beijing Choice Electronic Technology Co., Ltd.20168—
+4K153079Axeo 3 Patient MonitorAxeo Medical Technologies, LLC20160—
+4K151287Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70DGuangdong Biolight Meditech Co., Ltd.20160—
+4K150329elance Vital Signs Monitor, Central Monitor SoftwareSpacelabs Healthcare20150—
+4K150620740 SelectCas Medical Systems, Inc.201501
+4K141362Pulse Oximeter CMS50EWContec Medical Systems Co.,Ltd20151—
+4K142244Cleo Patient MonitorInfinium Medical201501
+4K131762Handheld MonitorGuangdong Biolight Meditech Co., Ltd.20147—
+4K131876M Series Patient MonitorMid-Link Consulting Co, Ltd.20140—
+4K132026V Series Monitoring System, 12.1 Dcu/V12 and 21.0 Dcu/V21Mindray DS USA, Inc.201321
+4K131763Truscope Series Patient MonitorGuangdong Biolight Meditech Co., Ltd.20130—
+4K130056Patient MonitorLd Technology, LLC20130—
+4K120631Patient MonitorAdvanced Instruments, Inc.20120—
+4K113833Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20123—
+4K112804Fingertip Pulse OximeterGuangdong Biolight Meditech Co., Ltd.20120—
+4K112803Patient MonitorGuangdong Biolight Meditech Co., Ltd.20110—
+4K102040Patient MonitorGuangdong Biolight Meditech Co., Ltd.20101—
+4K101694Handheld Pulse Oximeter Model M800Guangdong Biolight Meditech Co., Ltd.20100—
+5K232111NeoBeat, NeoBeat MiniLaerdal Medical AS20240—
+5K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+5K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+5K172141Pulse OximeterShanghai Berry Electronic Tech Co., Ltd.20180—
+5K170182Cardiovit FT-1Schiller AG20170—
+5K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+5K153135Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20162—
+5K150869Checkme Pro Health MonitorViatom Technology Co., Ltd.20155—
+5K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—
+6K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+6K230415Cadwell GuardianCadwell Industries, Inc.20230—
+6K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+6K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health)20210—
+6K191088Checkme O2 Pulse OximeterShenzhen Viatom Technology Co., Ltd.20192—
+6K190090DynoSense Vital Sign Measuring SystemDynosense Corp.20190—
+6K181919Patient MonitorGuangdong Biolight Meditech Co., Ltd.20190—
+6K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+6K170538RVS-100 Vital Signs MonitorRudolf Riester GmbH20170—
+6K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+7K242876Pulse Oximeter ( PO2, PO2A, PO2B)Shenzhen Viatom Technology Co., Ltd.20250—
+7K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+7K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+7K213515WesperO2Wesper, Inc.20220—
+8K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302