FibriCheck— 510(k) K232804

Substantially Equivalent

Qompium NV

FDA 510(k) clearance K232804 for FibriCheck, Substantially Equivalent on 2024-06-07. Applicant: Qompium NV. Device class: 2.

Clearance details

Applicant: Qompium NV
Product code: Code QME
Device class: Class 2
Regulation: 21 CFR 870.2785
Advisory panel: Cardiovascular
Date received: 2023-09-12
Decision date: 2024-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hasselt, BE

Download summary PDF View on FDA.gov ↗

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More clearances from Qompium NV

K173872 — FibriCheck2018-09-28

Data sourced from openFDA. This site is unofficial and independent of the FDA.