FDA 510(k) Applications Submitted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd

FDA 510(k) Number Submission Date Device Name Applicant
K132779 09/05/2013 DC-N2/DC-N2S DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K123503 11/13/2012 DC-N3/DC-NS3 DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K153448 11/30/2015 Passport Series Patient Monitors (Including Passport 8, Passport 12) SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K210699 03/09/2021 Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9 Diagnostic Ultrasound Syst Shenzhen Mindray Bio-Medical Electronics Co., LTD
K201990 07/17/2020 DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound System Shenzhen Mindray Bio-medical Electronics Co., Ltd
K192410 09/04/2019 ZS3 and z.one pro Ultrasound Systems ShenZhen Mindray Bio-Medical Electronics Co., Ltd
K182636 09/24/2018 DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., LTD
K183660 12/27/2018 DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System Shenzhen Mindray Bio-Medical Electronics Co., LTD
K200643 03/11/2020 Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous Shenzhen Mindray Bio-Medical Electronics Co., LTD
K182603 09/21/2018 Z6 Diagnostic Ultrasound System Shenzhen Mindray Bio-medical Electronics Co., LTD
K072164 08/06/2007 DC-6 DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K220058 01/06/2022 BeneVision Central Monitoring System Shenzhen Mindray Bio-Medical Electronics Co., LTD
K221113 04/15/2022 Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor Shenzhen Mindray Bio-Medical Electronics Co., LTD
K172860 09/20/2017 Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound System/Resona 6S/Resona 6PRO/Resona 6OB Diagnostic Ultrasound System /Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System ShenZhen Mindray Bio-Medical Electronics Co., Ltd
K203391 11/18/2020 TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., LTD
K101041 04/14/2010 DC-7 DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K092691 09/02/2009 DC-7 DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K200001 01/02/2020 MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T Diagnostic Ultrasound System, MX8/ MX8T/ Vaus8/ ME8 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., LTD
K220051 01/06/2022 TE Air Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., LTD
K200251 02/03/2020 Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System ShenZhen Mindray Bio-Medical Electronics Co., Ltd
K210416 02/11/2021 M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., LTD
K183377 12/06/2018 DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., LTD
K093394 10/30/2009 BC-3200 AUTO HEMATOLOGY ANALYZER,M-30D DILUENT, M-30R RINSE, M-30CFL LYSE, M-30E-Z CLEANSER, M-30PROBE CLEANSER, BC-3D C SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K063500 11/20/2006 DC-6 DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K080192 01/25/2008 HYPERVISOR VI CENTRAL MONITORING SYSTEM (INCLUDING TMS) SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K130833 03/26/2013 DP-20 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM; DP-30 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K111435 05/23/2011 DP-50 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K113153 10/25/2011 DP-20 AND DP-30 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K053193 11/15/2005 PM-8000 EXPRESS PATIENT MONITOR, MODEL PM-8000 EXPRESS SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K070526 02/23/2007 DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K080640 03/06/2008 M5 DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K140690 03/19/2014 BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K070791 03/22/2007 PM SERIES PATIENT MONITORS, MODELS PM-9000 EXPRESS AND PM-8000 EXPRESS SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K060949 04/06/2006 DP-6600 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K061189 04/28/2006 DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K081320 05/12/2008 DC-3, DC-3T DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K061442 05/24/2006 PULSE OXIMETER, MODEL PM-50 SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K072018 07/23/2007 BS-200 CHEMISTRY ANALYZER, MODE BS-200 SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K062194 07/31/2006 HYPERVISOR VI CENTRAL MONITORING SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K052113 08/04/2005 DP-6600 ULTRASONIC DIAGNOSTIC IMAGING SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K072235 08/10/2007 PM-50 PULSE OXIMETER AND VS-800 VITAL SIGNS MONITOR SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K092449 08/10/2009 BENEVIEW T SERIES PATIENT MONITORS, MODELS BENEVIEW T8, T6 AND T5 SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K112377 08/17/2011 BS-400 CHEMISTRY ANALYZER, CLC 720 CHEMISTRY ANALYZER SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K072346 08/21/2007 PM-7000 PATIENT MONITOR SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K032733 09/04/2003 PM-8000 PATIENT MONITOR, MODEL 8000 SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K072581 09/13/2007 PM-60 PULSE OXIMETER SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K052693 09/28/2005 PM-50 PULSE OXIMETER SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K102865 09/30/2010 DC-7 DIAGNOSTIC ULTRASOUND SYSTEM, DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K123074 10/01/2012 IMEC, IPM AND BENEVIEW T1 PATIENT MONITORS SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K063055 10/05/2006 VS-800 VITAL SIGNS MONITOR SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K063407 11/09/2006 BC-3200 AUTO HEMATOLOGY ANALYZER SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K053234 11/18/2005 PM-9000 EXPRESS PATIENT MONITOR SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K073280 11/21/2007 BENEVIEW T SERIES PATIENT MONITORS, MODELS T8, T6 AND T5 SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K043348 12/06/2004 MODIFICATION TO PM-8000 PATIENT MONITOR SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K043563 12/27/2004 DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K060281 02/03/2006 VS-800 VITAL SIGNS MONITOR SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K053346 12/02/2005 MODIFICATION TO: DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-9900 SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K083505 11/26/2008 DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K090912 04/01/2009 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-6900 SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K091941 06/30/2009 DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K083001 10/08/2008 M5 DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K140030 01/06/2014 DC-N3/DC-N3S DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K142552 09/10/2014 A7 Anesthesia System ShenZhen Mindray Bio-Medical Electronics Co., Ltd
K150167 01/26/2015 V60 Anesthetic Vaporizer SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K160381 02/10/2016 TE7 Diagnostic Ultrasound System SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K120699 03/07/2012 DC-T6 DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K130695 03/14/2013 Z5 DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K161525 06/02/2016 TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd
K152543 09/04/2015 M9/M9CV/M9T Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd
K150204 01/29/2015 DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound Systems SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K170277 01/30/2017 DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K121010 04/03/2012 M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K180912 04/06/2018 TE7/TE5 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd
K171579 05/31/2017 M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd
K131690 06/10/2013 M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K122010 07/09/2012 Z6 DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K152545 09/08/2015 DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound Systems SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K172970 09/26/2017 M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound ShenZhen Mindray Bio-Medical Electronics Co., Ltd
K173471 11/08/2017 DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic Shenzhen Mindray Bio-medical Electronics Co., LTD
K143472 12/05/2014 TE7 Diagnostic Ultrasound System SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K150082 01/15/2015 Panorama Patient Monitoring Network SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K150352 02/11/2015 V Series Monitoring System (including V12 and V21 Monitors) SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K150632 03/11/2015 Hypervisor IX Monitoring System SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K180788 03/26/2018 Gas Module 3 SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K211475 05/12/2021 Vital Signs Monitors Shenzhen Mindray Bio-Medical Electronics Co., LTD
K171901 06/26/2017 uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S) Shenzhen Mindray Bio-Medical Electronics Co., Ltd
K162607 09/19/2016 BeneVision Central Monitoring System Shenzhen Mindray Bio-Medical Electronics Co., Ltd
K152902 10/01/2015 Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K160370 02/10/2016 BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K150080 01/15/2015 DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K110199 01/24/2011 DC-T6 DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K100830 03/24/2010 M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K171891 06/26/2017 ZS3 Ultrasound System, z.one pro Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd
K132341 07/26/2013 DC-8/ DC-8 PRO/ DC-8 CV/ DC-8 EXP/ DC-8S DIAGNOSTIC ULTRASOUND SYSTEMS SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K152763 09/24/2015 Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K102991 10/07/2010 M5 DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K123185 10/10/2012 DC-8/DC-8 PRO/DC-8, CV/DC-8, EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K103583 12/07/2010 DC-7 DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K113647 12/12/2011 DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K103677 12/16/2010 M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K190206 02/04/2019 DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System Shenzhen Mindray Bio-medical Electronics Co., LTD
K211337 05/03/2021 DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., LTD
K221496 05/23/2022 Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE, Consona AT, Consona N6 Exp Diagnostic Ultrasound System, Consona N6 Elite, Consona N6T Diagnostic Ultrasound System Shenzhen Mindray Bio-medical Electronics Co., Ltd
K181637 06/21/2018 DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., LTD
K192152 08/09/2019 DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., LTD


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