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510(k) K241554

Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L) by Telefield Medical Imaging (Shenzhen) Limited — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2024
Date Received
May 31, 2024
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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