FDA 510(k) Applications Submitted by Zhang Wei
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| 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 |
| K190217 |
02/04/2019 |
Aidite PMMA |
Aidite (Qinhuangdao) Technology 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 |
| K221300 |
05/05/2022 |
Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite, Resona N9, Consona N9T, Consona N8, Consona N8 Pro, Consona N8 Super, Consona OR, Consona N8S, Consona O |
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 |
| 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. |
| K212377 |
08/02/2021 |
Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01 |
Ningbo MedKinetic Medical Device 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 |
| K192231 |
08/16/2019 |
Dental Glass Ceramics Blocks |
Aidite (Qinhuangdao) Technology Co., Ltd. |
| K222928 |
09/26/2022 |
Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic Ultrasound Sysem, Nuewa R9 Pro/ Nuewa R9S/ Resona 7/ Resona 7CV/Resona 7EXP/Resona 7S/ Resona 70B Diagnostic Ultrasound System, Resona 7PRO/Imagyn 7/ Resona Y/Resona R9 |
Shenzhen Mindray Bio-Medical Electronics Co.,LTD |
| K192723 |
09/27/2019 |
Coloring Liquid |
Aidite (Qinhuangdao) Technology Co., Ltd. |
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