Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Class II · Cleared Nov 16, 2021
| K-number | K212265 |
| Device name | 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 |
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. |
| Product code | IYN |
| Device class | Class II |
| Decision date | Nov 16, 2021 |
| Decision | Substantially Equivalent |
| Regulation | 892.1550 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov