FDA 510(k) · Qompium / FibriCheck
K173872: FibriCheck (Qompium NV)
Qompium NV received FDA 510(k) K173872 for FibriCheck, with a decision date of Sep 28, 2018 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K173872 |
|---|---|
| Pathway | 510(k) |
| Applicant | Qompium NV |
| Device name | FibriCheck |
| Product code | DXH: Transmitters And Receivers, Electrocardiograph, Telephone |
| Regulation (21 CFR) | 870.2920 |
| Device class | Class 2 |
| Date received | Dec 20, 2017 |
| Decision date | Sep 28, 2018 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
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.
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
Later records that cite K173872
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code DXH is "Transmitters And Receivers, Electrocardiograph, Telephone", class 2, 21 CFR 870.2920.
Our labels for filtering: claim ECG, sensor ECG electrodes. These are heuristics, not FDA fields.