FDA 510(k) Applications Submitted by Shenzhen Mindray Bio-medical Electronics Co., Ltd.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K242231 |
07/30/2024 |
Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System |
Shenzhen Mindray Bio-medical Electronics Co., LTD. |
| 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. |
| K240115 |
01/16/2024 |
Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, NuewaI8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY Diagnostic Ultrasound System |
Shenzhen Mindray Bio-medical Electronics Co., LTD. |
| K240684 |
03/12/2024 |
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, Resona I9W, Recho I9, Rec |
Shenzhen Mindray Bio-medical Electronics Co., LTD. |
| K241432 |
05/21/2024 |
MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System |
Shenzhen Mindray Bio-medical Electronics Co., LTD. |
| K250020 |
01/03/2025 |
Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9); Diagnostic Ultrasound System (Recho R9 Pro); Diagnostic Ultrasound System (Recho R9 Exp); Diagnostic Ultrasound System (Recho R9S); Diagnostic Ultrasound System (Recho R9T) |
Shenzhen Mindray Bio-medical Electronics Co., Ltd. |
| K250110 |
01/16/2025 |
Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic Ultrasound System (MX6T); Diagnostic Ultrasound System (MX6 Exp); Diagnostic Ultrasound System (MX6 Pro); Diagnostic Ultrasound System (MX6 Super); Diagnostic Ultrasound S |
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. |
| K240375 |
02/07/2024 |
V80 Anesthetic Vaporizer (V80) |
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. |
| K240906 |
04/02/2024 |
TE Air Diagnostic Ultrasound System |
Shenzhen Mindray Bio-medical Electronics Co., LTD. |
| K241201 |
04/30/2024 |
TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite/Anesus TEX20 Pro/Eagus TEX20/Eagus TEX20T/Eagus TEX21/Eagus TEX21T/Eros/TE X Plus/Anesus TEX10 Pro/TEX9U/TEX9M/Eagus TEX11/Eagus TEX11T/ |
Shenzhen Mindray Bio-medical Electronics Co., Ltd. |
| K231685 |
06/09/2023 |
TE Air Diagnostic Ultrasound System |
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. |
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