FDA.reportPublic FDA data

510(k) K232804

Device
FibriCheck
Applicant
Qompium NV
510(k) number
K232804
Product code
QME
Decision
Substantially Equivalent (SESE)
Decision date
2024-06-07
Date received
2023-09-12
Regulation
870.2785
Classification name
Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jo Van der Auwera
Address
Kempische Steenweg 303/27 Hasselt BE 3500 3500

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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