Devices · Shenzhen Mindray Bio-Medical Electronics Co.,LTD
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 is listed for 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 (K212265). The FDA list gives November 16, 2021 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is IYN. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212265
- Date of final decision
- November 16, 2021
- Company on the FDA list
- Shenzhen Mindray Bio-Medical Electronics Co.,LTD
- Lead panel
- Radiology
- Primary product code
- IYN
- openFDA device name for the code
- System, Imaging, Pulsed Doppler, Ultrasonic
- Device class
- 2
- Regulation number
- 892.1550
- openFDA decision description
- Substantially Equivalent
- openFDA decision code
- SESE
- Statement or summary label
- Summary