Clarius AI
K-Number: K222406 · 2023-01-23
ApplicantClarius Mobile Health Corp.
Decision Date2023-01-23
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Clarius AI is a medical device manufactured by Clarius Mobile Health Corp.. It received FDA 510(k) clearance on 2023-01-23 under approval number K222406. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Clarius AI?
Clarius AI is a medical device that received FDA 510(k) clearance on 2023-01-23. It is manufactured by Clarius Mobile Health Corp.. The 510(k) number is K222406.
When was Clarius AI approved by the FDA?
Clarius AI received FDA 510(k) clearance on 2023-01-23, under approval number K222406.
What company makes Clarius AI?
Clarius AI is manufactured by Clarius Mobile Health Corp..
What is the FDA product code for Clarius AI?
The FDA product code for Clarius AI is QIH.
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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.