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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