Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521)
K-Number: K230520 · 2023-03-21
ApplicantBarco N.V.
Decision Date2023-03-21
Product CodePGY
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521) is a medical device manufactured by Barco N.V.. It received FDA 510(k) clearance on 2023-03-21 under approval number K230520. 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-2521); Nio Color 3MP (MDNC-3521)?
Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521) is a medical device that received FDA 510(k) clearance on 2023-03-21. It is manufactured by Barco N.V.. The 510(k) number is K230520.
When was Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521) approved by the FDA?
Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521) received FDA 510(k) clearance on 2023-03-21, under approval number K230520.
What company makes Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521)?
Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521) is manufactured by Barco N.V..
What is the FDA product code for Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521)?
The FDA product code for Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521) 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.