Cleo
K-Number: K232011 · 2023-07-07
ApplicantAmerican Orthodontics
Decision Date2023-07-07
Product CodeNJM
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Cleo is a medical device manufactured by American Orthodontics. It received FDA 510(k) clearance on 2023-07-07 under approval number K232011. The device is classified under product code NJM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Cleo?
Cleo is a medical device that received FDA 510(k) clearance on 2023-07-07. It is manufactured by American Orthodontics. The 510(k) number is K232011.
When was Cleo approved by the FDA?
Cleo received FDA 510(k) clearance on 2023-07-07, under approval number K232011.
What company makes Cleo?
Cleo is manufactured by American Orthodontics.
What is the FDA product code for Cleo?
The FDA product code for Cleo is NJM.
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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.