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FDA 510(k)

NIO 2MP (MDNG-2121)

K-Number: K091172 · 2009-05-05

ApplicantBarco N.V.
Decision Date2009-05-05
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NIO 2MP (MDNG-2121) 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 2009-05-05 under 510(k) number K091172. 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 NIO 2MP (MDNG-2121)?

NIO 2MP (MDNG-2121) is a medical device that received FDA 510(k) clearance on 2009-05-05. The listed applicant is Barco N.V.. The 510(k) number is K091172.

When did NIO 2MP (MDNG-2121) receive FDA 510(k) clearance?

NIO 2MP (MDNG-2121) received FDA 510(k) clearance on 2009-05-05, under 510(k) number K091172.

Who is the listed applicant for NIO 2MP (MDNG-2121)?

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 NIO 2MP (MDNG-2121)?

The FDA product code for NIO 2MP (MDNG-2121) is LLZ.

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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