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FDA 510(k)

FibriCheck

K-Number: K232804 · 2024-06-07

ApplicantQompium NV
Decision Date2024-06-07
Product CodeQME
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FibriCheck is a medical device manufactured by Qompium NV. It received FDA 510(k) clearance on 2024-06-07 under approval number K232804. The device is classified under product code QME. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FibriCheck?

FibriCheck is a medical device that received FDA 510(k) clearance on 2024-06-07. It is manufactured by Qompium NV. The 510(k) number is K232804.

When was FibriCheck approved by the FDA?

FibriCheck received FDA 510(k) clearance on 2024-06-07, under approval number K232804.

What company makes FibriCheck?

FibriCheck is manufactured by Qompium NV.

What is the FDA product code for FibriCheck?

The FDA product code for FibriCheck is QME.

Other Devices by Qompium NV

K173872FibriCheck

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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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