Guidion
K-Number: K210110 · 2021-03-31
ApplicantImds Operations B.V.
Decision Date2021-03-31
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Guidion is a medical device manufactured by Imds Operations B.V.. It received FDA 510(k) clearance on 2021-03-31 under approval number K210110. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Guidion?
Guidion is a medical device that received FDA 510(k) clearance on 2021-03-31. It is manufactured by Imds Operations B.V.. The 510(k) number is K210110.
When was Guidion approved by the FDA?
Guidion received FDA 510(k) clearance on 2021-03-31, under approval number K210110.
What company makes Guidion?
Guidion is manufactured by Imds Operations B.V..
What is the FDA product code for Guidion?
The FDA product code for Guidion is DQY.
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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.