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510(k) K260190

ARTHUR by ROPCA ApS — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2026
Date Received
January 22, 2026
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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