FDA 510(k)

FibriCheck

K-Number: K232804 · 2024-06-07

Decision Date2024-06-07

Product CodeQME

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

FibriCheck is the device name listed in this FDA 510(k) record. The listed applicant is Qompium NV. It received FDA 510(k) clearance on 2024-06-07 under 510(k) 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. The listed applicant is Qompium NV. The 510(k) number is K232804.

When did FibriCheck receive FDA 510(k) clearance?

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

Who is the listed applicant for FibriCheck?

The FDA 510(k) record lists Qompium NV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FibriCheck?

The FDA product code for FibriCheck is QME.

Other records listing Qompium NV as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K173872FibriCheck

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Official Source

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