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FDA 510(k)

CORONIS FUSION 6MP

K-Number: K130103 · 2013-02-08

ApplicantBarco N.V.
Decision Date2013-02-08
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CORONIS FUSION 6MP 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 2013-02-08 under 510(k) number K130103. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORONIS FUSION 6MP?

CORONIS FUSION 6MP is a medical device that received FDA 510(k) clearance on 2013-02-08. The listed applicant is Barco N.V.. The 510(k) number is K130103.

When did CORONIS FUSION 6MP receive FDA 510(k) clearance?

CORONIS FUSION 6MP received FDA 510(k) clearance on 2013-02-08, under 510(k) number K130103.

Who is the listed applicant for CORONIS FUSION 6MP?

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 FUSION 6MP?

The FDA product code for CORONIS FUSION 6MP is LLZ.

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Other records listing Barco N.V. as applicant

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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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