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510(k) K230066

Carnation series Diagnostic Ultrasound System by Shenzhen Wisonic Medical Technology Co. , Ltd. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2023
Date Received
January 9, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Device Class
Class II
Regulation Number
892.1550
Review Panel
RA
Submission Type

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  • K163712 — Clover 50/Clover60/Clover70 Diagnostic Ultrasound System (January 2, 2018)

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