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510(k) K250913

TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System by Jiangsu Tingsn Technology Co., Ltd. — Product Code OBJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 2025
Date Received
March 27, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Ultrasound, Intravascular
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
Submission Type

For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.

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