Nio Color 2MP (MDNC-2123)
K-Number: K171812 · 2017-07-19
ApplicantBarco N.V.
Decision Date2017-07-19
Product CodePGY
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Nio Color 2MP (MDNC-2123) is a medical device manufactured by Barco N.V.. It received FDA 510(k) clearance on 2017-07-19 under approval number K171812. 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 2MP (MDNC-2123)?
Nio Color 2MP (MDNC-2123) is a medical device that received FDA 510(k) clearance on 2017-07-19. It is manufactured by Barco N.V.. The 510(k) number is K171812.
When was Nio Color 2MP (MDNC-2123) approved by the FDA?
Nio Color 2MP (MDNC-2123) received FDA 510(k) clearance on 2017-07-19, under approval number K171812.
What company makes Nio Color 2MP (MDNC-2123)?
Nio Color 2MP (MDNC-2123) is manufactured by Barco N.V..
What is the FDA product code for Nio Color 2MP (MDNC-2123)?
The FDA product code for Nio Color 2MP (MDNC-2123) 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.