FibriCheck— 510(k) K173872

Substantially Equivalent

Qompium NV

FDA 510(k) clearance K173872 for FibriCheck, Substantially Equivalent on 2018-09-28. Applicant: Qompium NV.

Clearance details

Applicant: Qompium NV
Product code: Code DXH
Advisory panel: Cardiovascular
Date received: 2017-12-20
Decision date: 2018-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hasselt, BE

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