FDA 510(k) Applications Submitted by SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

FDA 510(k) Number Submission Date Device Name Applicant
K213799 12/06/2021 N Series Patient Monitors Shenzhen Mindray Bio-medical Electronics Co., LTD.
K171034 04/06/2017 M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic Ultrasound System, M8 Elite Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
K200411 02/19/2020 Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., LTD.
K200979 04/13/2020 DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System Shenzhen Mindray Bio-Medical Electronics Co., LTD.
K212900 09/13/2021 MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., LTD.
K151954 07/15/2015 A7 Anesthesia System SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
K163690 12/28/2016 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.
K190011 01/03/2019 Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) Shenzhen Mindray Bio-medical Electronics Co., LTD.
K200015 01/03/2020 ePM Series Patient monitors Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
K170876 03/24/2017 Passport Series Patient Monitors(Passport 12m, Passport 17m) Shenzhen Mindray Bio-medical Electronics Co., LTD.
K171292 05/02/2017 A7 Anesthesia System Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
K171311 05/02/2017 A5 Anesthesia System Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
K191769 07/01/2019 ePM Series Patient monitors Shenzhen Mindray Bio-medical Electronics Co., LTD.
K201957 07/14/2020 A8, A9 Anesthesia System Shenzhen Mindray Bio-Medical Electronics Co., LTD.
K182075 08/01/2018 BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1) Shenzhen Mindray Bio-medical Electronics Co., LTD.
K202405 08/21/2020 BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1 Shenzhen Mindray Bio-medical Electronics Co., LTD.
K182821 10/04/2018 Accutorr 7/VS-900/VS-900c Vital Signs Monitor Shenzhen Mindray Bio-medical Electronics Co., LTD.
K192972 10/24/2019 Patient Monitor Shenzhen Mindray Bio-medical Electronics Co., LTD.
K183238 11/20/2018 BeneVision Central Monitoring System Shenzhen Mindray Bio-medical Electronics Co., LTD.
K193391 12/06/2019 BeneVision Central Monitoring System Shenzhen Mindray Bio-medical Electronics Co., LTD.
K201693 06/22/2020 DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80AExp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd.


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