CDI OneView Monitoring System
K-Number: K234065 · 2024-04-25
Decision Date2024-04-25
Product CodeDRY
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
CDI OneView Monitoring System is a medical device manufactured by Terumo Cardiovascular Systems Corporation. It received FDA 510(k) clearance on 2024-04-25 under approval number K234065. The device is classified under product code DRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CDI OneView Monitoring System?
CDI OneView Monitoring System is a medical device that received FDA 510(k) clearance on 2024-04-25. It is manufactured by Terumo Cardiovascular Systems Corporation. The 510(k) number is K234065.
When was CDI OneView Monitoring System approved by the FDA?
CDI OneView Monitoring System received FDA 510(k) clearance on 2024-04-25, under approval number K234065.
What company makes CDI OneView Monitoring System?
CDI OneView Monitoring System is manufactured by Terumo Cardiovascular Systems Corporation.
What is the FDA product code for CDI OneView Monitoring System?
The FDA product code for CDI OneView Monitoring System is DRY.
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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.