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FDA 510(k)

Nio Color 3MP (MDNC-3421)

K-Number: K170837 · 2017-04-05

ApplicantBarco N.V.
Decision Date2017-04-05
Product CodePGY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Nio Color 3MP (MDNC-3421) is a medical device manufactured by Barco N.V.. It received FDA 510(k) clearance on 2017-04-05 under approval number K170837. 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 Nio Color 3MP (MDNC-3421)?

Nio Color 3MP (MDNC-3421) is a medical device that received FDA 510(k) clearance on 2017-04-05. It is manufactured by Barco N.V.. The 510(k) number is K170837.

When was Nio Color 3MP (MDNC-3421) approved by the FDA?

Nio Color 3MP (MDNC-3421) received FDA 510(k) clearance on 2017-04-05, under approval number K170837.

What company makes Nio Color 3MP (MDNC-3421)?

Nio Color 3MP (MDNC-3421) is manufactured by Barco N.V..

What is the FDA product code for Nio Color 3MP (MDNC-3421)?

The FDA product code for Nio Color 3MP (MDNC-3421) is PGY.

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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.