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FDA 510(k)

ONE-CUF

K-Number: K230145 · 2023-03-14

ApplicantGe Medical Systems Information Technologies, Inc.
Decision Date2023-03-14
Product CodeDXQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ONE-CUF is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Information Technologies, Inc.. It received FDA 510(k) clearance on 2023-03-14 under 510(k) 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. The listed applicant is Ge Medical Systems Information Technologies, Inc.. The 510(k) number is K230145.

When did ONE-CUF receive FDA 510(k) clearance?

ONE-CUF received FDA 510(k) clearance on 2023-03-14, under 510(k) number K230145.

Who is the listed applicant for ONE-CUF?

The FDA 510(k) record lists Ge Medical Systems Information Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ONE-CUF?

The FDA product code for ONE-CUF is DXQ.

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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.

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