Nio Fusion 12MP (MDNC-12130)
K-Number: K203106 · 2020-11-10
ApplicantBarco N.V.
Decision Date2020-11-10
Product CodePGY
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Nio Fusion 12MP (MDNC-12130) is a medical device manufactured by Barco N.V.. It received FDA 510(k) clearance on 2020-11-10 under approval number K203106. 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 Fusion 12MP (MDNC-12130)?
Nio Fusion 12MP (MDNC-12130) is a medical device that received FDA 510(k) clearance on 2020-11-10. It is manufactured by Barco N.V.. The 510(k) number is K203106.
When was Nio Fusion 12MP (MDNC-12130) approved by the FDA?
Nio Fusion 12MP (MDNC-12130) received FDA 510(k) clearance on 2020-11-10, under approval number K203106.
What company makes Nio Fusion 12MP (MDNC-12130)?
Nio Fusion 12MP (MDNC-12130) is manufactured by Barco N.V..
What is the FDA product code for Nio Fusion 12MP (MDNC-12130)?
The FDA product code for Nio Fusion 12MP (MDNC-12130) 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.