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FDA 510(k)

SmartCardia 7L Platform

K-Number: K231276 · 2023-08-30

ApplicantSmartcardia SA
Decision Date2023-08-30
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SmartCardia 7L Platform is a medical device manufactured by Smartcardia SA. It received FDA 510(k) clearance on 2023-08-30 under approval number K231276. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SmartCardia 7L Platform?

SmartCardia 7L Platform is a medical device that received FDA 510(k) clearance on 2023-08-30. It is manufactured by Smartcardia SA. The 510(k) number is K231276.

When was SmartCardia 7L Platform approved by the FDA?

SmartCardia 7L Platform received FDA 510(k) clearance on 2023-08-30, under approval number K231276.

What company makes SmartCardia 7L Platform?

SmartCardia 7L Platform is manufactured by Smartcardia SA.

What is the FDA product code for SmartCardia 7L Platform?

The FDA product code for SmartCardia 7L Platform is DSI.

Other Devices by Smartcardia SA

K240653SmartCardia 7L Platform (MCT)

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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.

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