FDA product code QMW: Coronary Artery Disease Risk Indicator From Acoustic Heart Signals
QMW is the FDA product code for coronary artery disease risk indicator from acoustic heart signals. It is a Class II device, regulated under 21 CFR 870.1420 and reviewed by the Cardiovascular panel. Devices under QMW reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
A coronary artery disease risk indicator using acoustic heart signals is a device that records heart sounds including murmurs and vibrations to calculate a patient-specific risk of presence of coronary artery disease, as an aid in cardiac analysis and diagnosis.
Classification
| Field | Value |
|---|---|
| Device name | Coronary Artery Disease Risk Indicator From Acoustic Heart Signals |
| Device class | Class II |
| Regulation | 21 CFR 870.1420 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
Recalls for QMW devices
openFDA lists no recalls for product code QMW.
Frequently asked questions
What is FDA product code QMW?
QMW is the FDA product code for coronary artery disease risk indicator from acoustic heart signals. It is a Class II device, regulated under 21 CFR 870.1420 and reviewed by the Cardiovascular panel.
What device class is QMW?
Class II, regulation 21 CFR 870.1420. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QMW
- Run a recall and safety report across every QMW manufacturer
- Watch product code QMW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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