510(k) K232804— FibriCheck

Substantially Equivalent

Qompium NV

Clearance details

Applicant: Qompium NV
Product code: Code QME
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 ↗

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