MDPC-8127
K-Number: K203364 · 2021-04-15
ApplicantBarco N.V.
Decision Date2021-04-15
Product CodePSY
Advisory CommitteePA
DecisionSubstantially Equivalent
Device Summary
MDPC-8127 is a medical device manufactured by Barco N.V.. It received FDA 510(k) clearance on 2021-04-15 under approval number K203364. The device is classified under product code PSY. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the MDPC-8127?
MDPC-8127 is a medical device that received FDA 510(k) clearance on 2021-04-15. It is manufactured by Barco N.V.. The 510(k) number is K203364.
When was MDPC-8127 approved by the FDA?
MDPC-8127 received FDA 510(k) clearance on 2021-04-15, under approval number K203364.
What company makes MDPC-8127?
MDPC-8127 is manufactured by Barco N.V..
What is the FDA product code for MDPC-8127?
The FDA product code for MDPC-8127 is PSY.
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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.