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510(k) K244007

ArteVu by Cardio Ring Technologies, Inc. Taiwan Branch — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2025
Date Received
December 26, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Device Class
Class II
Regulation Number
870.1130
Review Panel
CV
Submission Type

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