FDA 510(k)

Coronis OneLook

K号: K242008 · 2024-08-02

决定日期2024-08-02

产品代码PGY

咨询委员会RA

决定实质等同

器械摘要

Coronis OneLook is the device name listed in this FDA 510(k) record. The listed applicant is Barco N.V.. It received FDA 510(k) clearance on 2024-08-02 under 510(k) number K242008. The device is classified under product code PGY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Coronis OneLook?

Coronis OneLook is a medical device that received FDA 510(k) clearance on 2024-08-02. The listed applicant is Barco N.V.. The 510(k) number is K242008.

When did Coronis OneLook receive FDA 510(k) clearance?

Coronis OneLook received FDA 510(k) clearance on 2024-08-02, under 510(k) number K242008.

Who is the listed applicant for Coronis OneLook?

The FDA 510(k) record lists Barco N.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Coronis OneLook?

The FDA product code for Coronis OneLook is PGY.

列明Barco N.V.为申报人的其他记录

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