FDA 510(k) Applications Submitted by Yanhong Bai
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| 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. |
| K220107 |
01/12/2022 |
Mindray SV600 Ventilator, Mindray SV800 Ventilator |
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 |
| K170712 |
03/09/2017 |
Accutorr 7/VS-900 Vital Signs Monitor |
Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. |
| K150632 |
03/11/2015 |
Hypervisor IX Monitoring System |
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. |
| K180788 |
03/26/2018 |
Gas Module 3 |
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. |
| 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 |
| 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. |
| K132662 |
08/26/2013 |
PASSPORT SERIES PATIENT MONITORS |
SHENZHEN MINDRAY BIOMEDICAL 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 |
| 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. |
| K143195 |
11/06/2014 |
Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1) |
Shenzhen Mindray Bio-Meidcal 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. |
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