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FDA 510(k)

Coronis OneLook

K-Number: K242008 · 2024-08-02

ApplicantBarco N.V.
Decision Date2024-08-02
Product CodePGY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Barco N.V. as applicant

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Related Devices (Code: PGY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261213Medical Monitor (40HT513D)Lg Electronics.IncK252780LCD Monitor (CL1902A, CL2103F)Shenzhen Beacon Display Technology Co., Ltd.K253242LCD Monitor (C1216W, C822W, C821W)Shenzhen Beacon Display Technology Co., Ltd.K252030RadiForce GX570; RadiForce GX570-AREizo CorporationK243221RadiForce RX570; RadiForce RX570-AREizo CorporationK243031LCD Monitors C310S, G310S, C316S, G316S, C616WShenzhen Beacon Display Technology 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.

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