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FDA 510(k)

CORONIS 2MP AND MDCG 2121 - CB

K-Number: K061926 · 2006-08-18

ApplicantBarcoview
Decision Date2006-08-18
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CORONIS 2MP AND MDCG 2121 - CB is the device name listed in this FDA 510(k) record. The listed applicant is Barcoview. It received FDA 510(k) clearance on 2006-08-18 under 510(k) number K061926. 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 2MP AND MDCG 2121 - CB?

CORONIS 2MP AND MDCG 2121 - CB is a medical device that received FDA 510(k) clearance on 2006-08-18. The listed applicant is Barcoview. The 510(k) number is K061926.

When did CORONIS 2MP AND MDCG 2121 - CB receive FDA 510(k) clearance?

CORONIS 2MP AND MDCG 2121 - CB received FDA 510(k) clearance on 2006-08-18, under 510(k) number K061926.

Who is the listed applicant for CORONIS 2MP AND MDCG 2121 - CB?

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

What is the FDA product code for CORONIS 2MP AND MDCG 2121 - CB?

The FDA product code for CORONIS 2MP AND MDCG 2121 - CB is LLZ.

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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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