ArteVu
K-Number: K244007 · 2025-07-30
Decision Date2025-07-30
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
ArteVu is a medical device manufactured by Cardio Ring Technologies, Inc. Taiwan Branch. It received FDA 510(k) clearance on 2025-07-30 under approval number K244007. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ArteVu?
ArteVu is a medical device that received FDA 510(k) clearance on 2025-07-30. It is manufactured by Cardio Ring Technologies, Inc. Taiwan Branch. The 510(k) number is K244007.
When was ArteVu approved by the FDA?
ArteVu received FDA 510(k) clearance on 2025-07-30, under approval number K244007.
What company makes ArteVu?
ArteVu is manufactured by Cardio Ring Technologies, Inc. Taiwan Branch.
What is the FDA product code for ArteVu?
The FDA product code for ArteVu is DXN.
Related Devices (Code: DXN)
K162092Evolv Model BP7000 Upper Arm Blood Pressure MonitorOmron Healthcare, Inc.
K161708Arm automatic blood pressure monitorShenzhen Pump Medical System Co., Ltd.
K162230Fully Automatic Electronic Blood Pressure MonitorAdon Health Co., Ltd.
K160349Electronic SphygmomanometerGuangdong Biolight Meditech Co., Ltd.
K161846Automatic Arm Bluetooth Blood Pressure MonitorTruly Instrument Limited
K161886Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure DeviceGuangdong Transtek Medical Electronics Co., Ltd.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.