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510(k) K233401

Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile) by Eieling Technology Limited — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2024
Date Received
October 4, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
Submission Type

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