FDA 510(k) Applications Submitted by SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K212265 |
07/20/2021 |
TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System |
Shenzhen Mindray Bio-Medical Electronics Co.,LTD |
| K220242 |
01/28/2022 |
TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System |
Shenzhen Mindray Bio-Medical Electronics Co.,LTD |
| K230768 |
03/20/2023 |
M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System |
Shenzhen Mindray Bio-Medical Electronics Co.,LTD |
| K162267 |
08/11/2016 |
Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD |
| K162845 |
10/11/2016 |
DC-40/DC-35/DC-45/DC-40S/DC-40 Pro 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 |
| 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 |
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