K232804

FibriCheck

510(k) number
K232804
Device name
FibriCheck
Applicant
Qompium NV BE
Product code
QME — Software For Optical Camera-Based Measurement Of Pul
Decision date
2024-06-07
Date received
2023-09-12
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain

Also available from FDA: K232804.pdf

Official FDA record: K232804
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.