510(k) Report

Devices descending from K002478

86 later devices reach S/5 Compact Anesthesia Monitor with S-00A05, S-00A06. L-00A07, L00A08 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K022485Datex-Ohmeda S/5 Compact Anesthesia Monitor with L-CANE02 and L-CANE02A SoftwareDatex-Ohmeda200285—
+2K041790Datex-Ohmeda S/5 Compact Anesthesia Monitor with L-CANE03 and LCANE03A SoftwareDatex-Ohmeda200484—
+3K073280Beneview T Series Patient Monitors, Models T8, T6 and T5Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20082—
+3K053193PM-8000 Express Patient Monitor, Model PM-8000 ExpressShenzhen Mindray Bio-Medical Electronics Co., Ltd.200648—
+3K061185Datex-Ohmeda S/5 Compact Anesthesia Monitor with L-CANE05A and L-CANE05A SoftwareGE Healthcare200634—
+4K110922Patient MonitorEdan Instruments, Inc.201111
+4K102239Carescape Monitor B650GE Healthcare Finland Oy2010328
+4K070791PM Series Patient Monitors, Models PM-9000 Express and PM-8000 ExpressShenzhen Mindray Bio-Medical Electronics Co., Ltd.200747—
+4K062324Mri Monitor with L-CANE05 and L-CANE05A Software and Module Options N-Psngv, N-PSNG…GE Healthcare20060—
+5K171580Monitor B125, Monitor B105Ge Medical Systems (China) Co., Ltd.201741
+5K132533Carescape Monitor B450GE Healthcare Finland Oy2013143
+5K131223Carescape Monitor B650GE Healthcare Finland Oy2013134
+5K130584Monitor B40Ge Medical Systems China Co., Ltd.201382
+5K112877Comen Multi-Parameter Patient MonitorGoldway (Us), Inc.20121—
+5K120598Procare Monitor B40Ge Medical Systems China Co., Ltd.2012102
+5K120631Patient MonitorAdvanced Instruments, Inc.20120—
+5K091834Passport V Monitor, Model 0998-00-6100Datascope Corp., Patient Monitoring Division200902
+5K082887PM-1000F+Patient MonitorAdvanced Instrumentations, Inc.20090—
+5K072581PM-60 Pulse OximeterShenzhen Mindray Bio-Medical Electronics Co., Ltd.200819—
+5K072346PM-7000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.200719—
+6K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+6K191249Carescape B450GE Healthcare Finland Oy20204—
+6K191149Carescape B650GE Healthcare Finland Oy202072
+6K190008Carescape OneGE Healthcare201911—
+6K173454Multi-parameter Patient Monitor, models C30Shenzhen Comen Medical Instruments Co.,Ltd20180—
+6K133576Monitor B40Ge Medical Systems China Co., Ltd.20147Class I
+6K122253Procare Monitor B20Ge Medical Systems China Co., Ltd.201302
+6K101692Patient MonitorContec Medical System Co., Ltd.201101
+6K100046M Seires Patient Monitor Model M66, M69, M8000, M9000, M7000Guangdong Biolight Meditech Co., Ltd.201016—
+6K092970General Patient Monitors, Models: G3C/ G3D/ G3F/ G3G/ G3HGeneral Meditech, Inc.20100—
+6K092727H100B Pulse OximeterEdan Instruments, Inc.20090—
+6K090599MD300K1 Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20099—
+6K090671Pulse Oximeter, Models CMS50E, CMS50F, CMS60C, CMS60DContec Medical System Co., Ltd.20093—
+6K081712Fingertip Pulse Oximeter, Model M70, and Handheld Pulse Oximeter, Model M700Guangdong Biolight Meditech Co., Ltd.20083—
+7K213181CARESCAPE B650, E-musbGE Healthcare Finland Oy202262
+7K213363CARESCAPE B450, E-musbGE Healthcare Finland Oy202211
+7K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+7K200494CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRESGE Healthcare2020101
+7K152563Pulse Oximeter (MD300M/MD300K2)Beijing Choice Electronic Technology Co., Ltd.20168—
+7K151287Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70DGuangdong Biolight Meditech Co., Ltd.20160—
+7K151063Monitor B40Ge Medical Systems China Co., Ltd.201551
+7K143676B40i Patient MonitorGE Healthcare Finland Oy201541
+7K141362Pulse Oximeter CMS50EWContec Medical Systems Co.,Ltd20151—
+7K131762Handheld MonitorGuangdong Biolight Meditech Co., Ltd.20147—
+7K131876M Series Patient MonitorMid-Link Consulting Co, Ltd.20140—
+7K131763Truscope Series Patient MonitorGuangdong Biolight Meditech Co., Ltd.20130—
+7K130056Patient MonitorLd Technology, LLC20130—
+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—
+8K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+8K232111NeoBeat, NeoBeat MiniLaerdal Medical AS20240—
+8K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+8K230579Smart Wedge algorithmEdwards Lifesciences, LLC20235—
+8K223498Radius VSM and AccessoriesMasimo Corporation202312
+8K213234CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG…Ge Medical Systems Information Technologies, Inc.202231
+8K212876Carescape SpO2 - MasimoMasimo Corporation20212—
+8K172141Pulse OximeterShanghai Berry Electronic Tech Co., Ltd.20180—
+8K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+8K153135Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20162—
+8K150869Checkme Pro Health MonitorViatom Technology Co., Ltd.20155—
+9K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+9K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP…GE Healthcare Finland Oy20260—
+9K250757Radius VSM and AccessoriesMasimo Corporation20250—
+9K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+9K230415Cadwell GuardianCadwell Industries, Inc.20230—
+9K221953Masimo CARESCAPE SpO2 – Masimo with SpHbMasimo Corporation20221—
+9K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+9K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health)20210—
+9K191088Checkme O2 Pulse OximeterShenzhen Viatom Technology Co., Ltd.20192—
+9K190090DynoSense Vital Sign Measuring SystemDynosense Corp.20190—
+9K181919Patient MonitorGuangdong Biolight Meditech Co., Ltd.20190—
+9K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+9K170538RVS-100 Vital Signs MonitorRudolf Riester GmbH20170—
+10K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+10K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+10K242876Pulse Oximeter ( PO2, PO2A, PO2B)Shenzhen Viatom Technology Co., Ltd.20250—
+10K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+10K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation20230—
+10K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+10K213515WesperO2Wesper, Inc.20220—
+11K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+11K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+11K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302