AeroEclipse* ONE BAN
K-Number: K200063 · 2020-07-17
ApplicantTrudell Medical International
Decision Date2020-07-17
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
AeroEclipse* ONE BAN is a medical device manufactured by Trudell Medical International. It received FDA 510(k) clearance on 2020-07-17 under approval number K200063. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the AeroEclipse* ONE BAN?
AeroEclipse* ONE BAN is a medical device that received FDA 510(k) clearance on 2020-07-17. It is manufactured by Trudell Medical International. The 510(k) number is K200063.
When was AeroEclipse* ONE BAN approved by the FDA?
AeroEclipse* ONE BAN received FDA 510(k) clearance on 2020-07-17, under approval number K200063.
What company makes AeroEclipse* ONE BAN?
AeroEclipse* ONE BAN is manufactured by Trudell Medical International.
What is the FDA product code for AeroEclipse* ONE BAN?
The FDA product code for AeroEclipse* ONE BAN is CAF.
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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.