510(k) Report

Devices descending from K842616

165 later devices reach Spacelabs Alpha PC Patient Computer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K972282Spacelabs Medical Pcis Patient MonitorsSpacelabs Medical, Inc.19971244
+1K962928Combined Intracranial Pressure-Temperature Sensing System (Icp/)Camino Neurocare, Inc.1996392
+2K121573Integra Camino Icp MonitorIntrgra Lifesciences Corporation201243
+2K121159Integra Camino Flex Ventricular Intracranial Pressure Monitoring Kit with Intrgra Camino…Integra Lifescience Corportation20122—
+2K120252Raumedic-Icp-Temp-Monitoring-SystemRaumedic AG20125—
+2K102875Camino 110-4B Olm Intracranial Pressure Mnitoring Kit; Camino 110-4G Post Craniotomy…Integra LifeSciences Corporation201023
+2K102422Spacelabs Medical Patient MonitorsSpacelabs Medical, Inc.201033
+2K101133Sensometrics SoftwareDpcom AS20100—
+2K072379MPS Oxiport and MPS Oxiport PlusInnerspace, Inc.20082—
+2K031086Camino Single Parameter Monitor, Model SPM-1Integra Neurosciences20030—
+2K020550Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXXDatascope Corp.2002751
+2K003759Aesculap Spiegelberg Brain Pressure MonitorAesculap, Inc.200111
+2K993531Passport 2 Vital Signs Monitor, Model 0998-00-0170-XXDatascope Corp.20001191
+2K980380Neurotrend Multiparameter Sensor, C7004S, to Operate with Paratrend 7+ Multiparameter…Diametrics Medical, Ltd.199927—
+3K250285Neurovent-P (092946-003); Neurovent (092956-003); Neurovent-Ifd-R (095317-003)…Raumedic AG20250—
+3K171666MPR2 logO DATALOGGERRaumedic AG20170—
+3K160667Anybattery C2 Rechargeable BatteryAnybattery, Inc.20170—
+3K162108Pressio 2 ICP Monitoring SystemSophysa SA201713
+3K161010HICP200 Patient/Monitor Interconnect CableInnerspace Neuro Solutions, Inc.20160—
+3K133754Integra Camino Flex Ventricular Intracranial Pressure Monitoring Kit with Flex AdapterIntegra LifeSciences Corporation20140—
+3K130529Raumedic-Pto-Monitoring-SystemRaumedic AG20134—
+3K131184Integra Licox PTO2 MonitorIntegra Lifesciences Corp.201305
+3K120616Spacelabs Healthcare Qube Compact Monitor (91390Spacelabs Medical, Inc.201209
+3K112962Spacelabs Healthcare Xprezzon Beside Monitor (9913930)Spacelabs Medical, Inc.201107
+3K101619Welch Allyn 1500 Patient MonitorSchiller AG20104—
+3K083378SynergyInnerspace, Inc.20091—
+3K090443Planet 55, Model 100Larsen & Toubro Limited20090—
+3K070791PM Series Patient Monitors, Models PM-9000 Express and PM-8000 ExpressShenzhen Mindray Bio-Medical Electronics Co., Ltd.200747—
+3K062144Escort M8 Vital Signs Patient Monitor, Model 3810Invivo Corporation200611—
+3K052544Pulse Oximeter Adapter CablesAmerican I.V. Products, Inc.20060—
+3K050702Neurosystems 1TM MonitorNeurosystems, LLC200517—
+3K041907Trio MonitorDatascope Corp.20040—
+3K032733PM-8000 Patient Monitor, Model 8000Shenzhen Mindray Bio-Medical Electronics Co., Ltd.200488—
+3K031849Spectrum Patient Monitor, Model 0998-00-0500-XxxxxDatascope Corp.200391
+3K020285Cma Cerebral Tissue Monitoring SystemCma Microdialysis AB20023—
+4K252241Pressio 3 Multi-parameter Neuromonitoring SystemSophysa20260—
+4K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd.20143—
+4K112877Comen Multi-Parameter Patient MonitorGoldway (Us), Inc.20121—
+4K091834Passport V Monitor, Model 0998-00-6100Datascope Corp., Patient Monitoring Division200902
+4K090556Spacelabs Elance Vital Signs Monitoring System and Central Monitor SoftwareSpacelabs Healthcare Medical Equipment (Suzhou) CO2009101
+4K082887PM-1000F+Patient MonitorAdvanced Instrumentations, Inc.20090—
+4K071984Modification to Cma Cerebral Tissue Monitoring SystemCma Microdialysis AB20081—
+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—
+4K062098Spectrum Monitor, Model 0998-00-1000-XxxxxDatascope Corp.20077—
+4K061640Integra Mobius Multi-Modality Monitoring SystemIntegra LifeSciences Corporation200615—
+4K060554Cma Cerebral Tissue Monitoring SystemCma Microdialysis AB20062—
+4K043348Modification to PM-8000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.200587—
+5K173454Multi-parameter Patient Monitor, models C30Shenzhen Comen Medical Instruments Co.,Ltd20180—
+5K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+5K132229Omni Patent MonitorsInfinium Medical20142—
+5K130740Nightingale Monitoring SystemZoe Medical, Inc.20133—
+5K123556Mortara Surveyor Patient MonitorMortara Instrument, Inc.201321
+5K110922Patient MonitorEdan Instruments, Inc.201111
+5K101692Patient MonitorContec Medical System Co., Ltd.201101
+5K102077Modification to Cma Cerebral Tissue Monitoring SystemCma Microdialysis AB20110—
+5K102004Endeavour Monitoring SystemMindray DS USA, Inc.201033
+5K093802Ultraview DM3 MonitorZoe Medical, Inc.201002
+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—
+5K093501Elance Vital Signs Monitor and Elance Central StationSpacelabs Medical, Inc.200912
+5K090599MD300K1 Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20099—
+5K090671Pulse Oximeter, Models CMS50E, CMS50F, CMS60C, CMS60DContec Medical System Co., Ltd.20093—
+5K080217Component Neuromonitoring SystemMoberg Research, Inc.2008141
+5K081712Fingertip Pulse Oximeter, Model M70, and Handheld Pulse Oximeter, Model M700Guangdong Biolight Meditech Co., Ltd.20083—
+5K063055VS-800 Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.200613—
+5K060281VS-800 Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.200616—
+5K053193PM-8000 Express Patient Monitor, Model PM-8000 ExpressShenzhen Mindray Bio-Medical Electronics Co., Ltd.200648—
+5K053234PM-9000 Express Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.2006711
+6K200878Natus NeuroWorksNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)20201—
+6K191868iCEWav Neuromonitoring PlatformIce Neurosystems, Inc.20200—
+6K192572CNS EnvisionMoberg Research, Inc.20190—
+6K173366NicoletOneNatus Neurology Incorporated20183—
+6K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+6K161517Mortara Surveyor Patient MonitorMortara Instrument, Inc.20171—
+6K152043Diagnostic Station DS20Schiller AG20161—
+6K152563Pulse Oximeter (MD300M/MD300K2)Beijing Choice Electronic Technology Co., Ltd.20168—
+6K153079Axeo 3 Patient MonitorAxeo Medical Technologies, LLC20160—
+6K151287Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70DGuangdong Biolight Meditech Co., Ltd.20160—
+6K150329elance Vital Signs Monitor, Central Monitor SoftwareSpacelabs Healthcare20150—
+6K150620740 SelectCas Medical Systems, Inc.201501
+6K141362Pulse Oximeter CMS50EWContec Medical Systems Co.,Ltd20151—
+6K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc.20150—
+6K142244Cleo Patient MonitorInfinium Medical201501
+6K131762Handheld MonitorGuangdong Biolight Meditech Co., Ltd.20147—
+6K131876M Series Patient MonitorMid-Link Consulting Co, Ltd.20140—
+6K132026V Series Monitoring System, 12.1 Dcu/V12 and 21.0 Dcu/V21Mindray DS USA, Inc.201321
+6K123711Patient MonitorShenzhen Creative Industry Co., Ltd.201313—
+6K131763Truscope Series Patient MonitorGuangdong Biolight Meditech Co., Ltd.20130—
+6K130056Patient MonitorLd Technology, LLC20130—
+6K120631Patient MonitorAdvanced Instruments, Inc.20120—
+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—
+6K100740MD2000B Vital Sign Monitor, Model MD2000BBeijing Choice Electronic Technololgy Co., Ltd.20102—
+6K092573Nihon Kohden QP-160AK Eeg Trend ProgramNihon Kohden America, Inc.20107—