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System, Imaging, Pulsed Doppler, Ultrasonic

FDA product code IYN · 1075 cleared devices

Class 2 Radiology
Regulation
21 CFR 892.1550
Review panel
RA
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
1978-10-10 – 2026-09-25
IYN 2022-09-29

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 OI, Consona OT, Consona N8 Exp, Consona N8 Elite, Consona N8T, Consona N7, Consona N7 Pro, Consona N7 Super, Consona VR, Consona N7S, Consona VI, Consona VT, Consona N7 Exp, Consona N7 Elite, Consona N7T Diagnostic Ultrasound System

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K number K221300

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