ONE-CUF
K-Number: K230145 · 2023-03-14
Decision Date2023-03-14
Product CodeDXQ
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
ONE-CUF is a medical device manufactured by Ge Medical Systems Information Technologies, Inc.. It received FDA 510(k) clearance on 2023-03-14 under approval number K230145. The device is classified under product code DXQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ONE-CUF?
ONE-CUF is a medical device that received FDA 510(k) clearance on 2023-03-14. It is manufactured by Ge Medical Systems Information Technologies, Inc.. The 510(k) number is K230145.
When was ONE-CUF approved by the FDA?
ONE-CUF received FDA 510(k) clearance on 2023-03-14, under approval number K230145.
What company makes ONE-CUF?
ONE-CUF is manufactured by Ge Medical Systems Information Technologies, Inc..
What is the FDA product code for ONE-CUF?
The FDA product code for ONE-CUF is DXQ.
Other Devices by Ge Medical Systems Information Technologies, Inc.
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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.