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FDA 510(k), K212265, 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
FDA 510(k), K212265, 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
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$149.00 USD
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$149.00 USD
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510(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
Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co.,LTD
Device Classification Name: System, Imaging, Pulsed Doppler, Ultrasonic
Regulation Number: 892.1550
Classification Product Code: IYN
Date Received: 07/20/2021
Decision Date: 11/16/2021
Regulation Medical Specialty: Radiology
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
Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co.,LTD
Device Classification Name: System, Imaging, Pulsed Doppler, Ultrasonic
Regulation Number: 892.1550
Classification Product Code: IYN
Date Received: 07/20/2021
Decision Date: 11/16/2021
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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