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510(k) Data Aggregation
K Number
K232804Device Name
FibriCheck
Manufacturer
Qompium nv
Date Cleared
2024-06-07
(269 days)
Product Code
QME, DXH
Regulation Number
870.2785Why did this record match?
Applicant Name (Manufacturer) :
Qompium nv
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FibriCheck is indicated for self-testing by patients who have been diagnosed with, or are susceptible to developing, atrial fibrillation and who would like to monitor and record their heart rhythms on an intermittent basis.
Device Description
FibriCheck is a medical device software that can be used to determine heart rhythm conditions, with a primary focus on the detection of atrial fibrillation.
The FibriCheck Mobile Application is a smartphone application for patients intended to record, display, store and transmit photoplethysmography (PG) data. Heart rhythm measurements are performed by placing the fingertip on the camera of a smartphone device. This way, volumetric changes can be detected.
The FibriCheck Portal is a web application for healthcare providers intended to display data that was captured by the FibriCheck Mobile Application. Healthcare providers can use the issue FibriCheck prescriptions, to manage their patients and to consult measurement data.
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K Number
K173872Device Name
FibriCheck
Manufacturer
Qompium nv
Date Cleared
2018-09-28
(282 days)
Product Code
DXH
Regulation Number
870.2920Why did this record match?
Applicant Name (Manufacturer) :
Qompium nv
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FibriCheck is indicated for self-testing by patients who have been diagnosed with, or are susceptible to developing, atrial fibrillation and who would like to monitor and record their heart rhythms on an intermittent basis.
Device Description
FibriCheck is medical device software that determines heart rhythm conditions, with a primarily focus on the detection of Atrial Fibrillation. It makes use of optical sensing from a mobile device to collect photoplethysmogram data (PPG data). The recordings can be shared optionally with a physician or monitoring service.
The FibriCheck web application, an online tool, has the sole intention to display data. Professional users can use the web application for managing patients and reviewing FibriCheck data.
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