The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co.,ltd with the FDA for 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.
| Device ID | K220242 |
| 510k Number | K220242 |
| Device Name: | 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 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co.,LTD Keji 12th Road South, Hi-tech Industrial Park Shenzhen, CN 518057 |
| Contact | Jiang Xiaoyong |
| Correspondent | Jiang Xiaoyong Shenzhen Mindray Bio-Medical Electronics Co.,LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan Shenzhen, CN 518057 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-28 |
| Decision Date | 2022-03-25 |