K244007

ArteVu

510(k) number
K244007
Device name
ArteVu
Applicant
Cardio Ring Technologies, Inc. Taiwan Branch TW
Product code
DXN — System, Measurement, Blood-Pressure, Non-Invasive
Decision date
2025-07-30
Date received
2024-12-26
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Cardiovascular
510(k) Summary (official FDA PDF): K244007.pdf
Official FDA record: K244007
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.