510(k) Report

Devices descending from K000815

56 later devices reach AS/3 Anesthesia Montior with S-ANE99(a)/L-ARK99(a) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K021279Datex-Ohmeda S/5 Anesthesia Monitor with L-ANE02 and L-ANE02A SoftwareDatex-Ohmeda200255—
+2K030812Datex-Ohmeda S/5 Anesthesia Monitor with L-AN03 and L-ANE03A SoftwareDatex-Ohmeda200354—
+3K071097Navigator Applications SuiteGE Healthcare Finland Oy20074—
+3K051400Datex-Ohmeda S/5 Anesthesia Monitor with L-ANEO5 and L-ANEO5A Software, Using F-CU8 or…GE Healthcare200648—
+4K103035Smartpilot View Model MK04500Draeger Medical GmbH20120—
+4K102389Navigator Applications SuiteGE Healthcare Finland Oy20111—
+4K092680Datex-Ohmeda S/5 Anesthesia Monitor with L-ANEO7 and L-ANEO7A Software Using F-CU8 or…GE Healthcare Finland Oy200933—
+4K092027Carescape Monitor B850Ge Medical Systems Information Technologies2009389
+4K083098Navigator Applications SuiteGE Healthcare Finland Oy20092—
+4K081941Navigator Applications SuiteGE Healthcare Finland Oy20083—
+4K062098Spectrum Monitor, Model 0998-00-1000-XxxxxDatascope Corp.20077—
+5K132229Omni Patent MonitorsInfinium Medical20142—
+5K131414Carescape Monitor B850GE Healthcare Finland Oy2013103
+5K102239Carescape Monitor B650GE Healthcare Finland Oy2010328
+5K102004Endeavour Monitoring SystemMindray DS USA, Inc.201033
+6K191323Carescape B850GE Healthcare Finland Oy202071
+6K191249Carescape B450GE Healthcare Finland Oy20204—
+6K171580Monitor B125, Monitor B105Ge Medical Systems (China) Co., Ltd.201741
+6K153079Axeo 3 Patient MonitorAxeo Medical Technologies, LLC20160—
+6K142244Cleo Patient MonitorInfinium Medical201501
+6K132026V Series Monitoring System, 12.1 Dcu/V12 and 21.0 Dcu/V21Mindray DS USA, Inc.201321
+6K132533Carescape Monitor B450GE Healthcare Finland Oy2013143
+6K131223Carescape Monitor B650GE Healthcare Finland Oy2013134
+6K130584Monitor B40Ge Medical Systems China Co., Ltd.201382
+6K120598Procare Monitor B40Ge Medical Systems China Co., Ltd.2012102
+7K213363CARESCAPE B450, E-musbGE Healthcare Finland Oy202211
+7K213336Carescape B850, E-musbGE Healthcare Finland Oy202221
+7K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+7K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+7K191149Carescape B650GE Healthcare Finland Oy202072
+7K190008Carescape OneGE Healthcare201911—
+7K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—
+7K133576Monitor B40Ge Medical Systems China Co., Ltd.20147Class I
+7K122253Procare Monitor B20Ge Medical Systems China Co., Ltd.201302
+8K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+8K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+8K223531CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame…GE Healthcare Finland Oy202313
+8K213181CARESCAPE B650, E-musbGE Healthcare Finland Oy202262
+8K200494CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRESGE Healthcare2020101
+8K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+8K151063Monitor B40Ge Medical Systems China Co., Ltd.201551
+8K143676B40i Patient MonitorGE Healthcare Finland Oy201541
+9K260343Carescape Canvas 1000; Carescape Canvas Smart DisplayGE Healthcare Finland Oy20260—
+9K230579Smart Wedge algorithmEdwards Lifesciences, LLC20235—
+9K223498Radius VSM and AccessoriesMasimo Corporation202312
+9K213234CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG…Ge Medical Systems Information Technologies, Inc.202231
+9K212876Carescape SpO2 - MasimoMasimo Corporation20212—
+10K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP…GE Healthcare Finland Oy20260—
+10K250757Radius VSM and AccessoriesMasimo Corporation20250—
+10K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+10K221953Masimo CARESCAPE SpO2 – Masimo with SpHbMasimo Corporation20221—
+11K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+11K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+11K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation20230—
+12K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+12K253034HemoSphere Stream ModuleEdwards Lifesciences20250—