SmartCardia 7L Platform (MCT)
K-Number: K240653 · 2024-10-31
ApplicantSmartcardia SA
Decision Date2024-10-31
Product CodeQYX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
SmartCardia 7L Platform (MCT) is a medical device manufactured by Smartcardia SA. It received FDA 510(k) clearance on 2024-10-31 under approval number K240653. The device is classified under product code QYX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SmartCardia 7L Platform (MCT)?
SmartCardia 7L Platform (MCT) is a medical device that received FDA 510(k) clearance on 2024-10-31. It is manufactured by Smartcardia SA. The 510(k) number is K240653.
When was SmartCardia 7L Platform (MCT) approved by the FDA?
SmartCardia 7L Platform (MCT) received FDA 510(k) clearance on 2024-10-31, under approval number K240653.
What company makes SmartCardia 7L Platform (MCT)?
SmartCardia 7L Platform (MCT) is manufactured by Smartcardia SA.
What is the FDA product code for SmartCardia 7L Platform (MCT)?
The FDA product code for SmartCardia 7L Platform (MCT) is QYX.
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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.