Data / Medical devices / Coronary Artery Disease Risk Indicator From Acoustic Heart Signals
Coronary Artery Disease Risk Indicator From Acoustic Heart Signals (QMW): 3 FDA-registered makers in 2 countries
3 establishments in 2 countries are registered with the FDA to make Coronary Artery Disease Risk Indicator From Acoustic Heart Signals (product code QMW, Class 2, 21 CFR 870.1420). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on November 24, 2020, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QMW
- Device class
- 2
- Regulation
- 870.1420
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| Denmark | 2 |
| China | 1 |
Makers of Coronary Artery Disease Risk Indicator From Acoustic Heart Signals
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Acarix AS | Hellerup Hovedstaden, Denmark | Manufacturer, Specification developer | 1 | November 24, 2020 | 0 | 0 | 0 | api.fda.gov |
| Linxens Healthcare (Tianjin) Co., Ltd | JinNan District Tianjin, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paul E. Danchell A/S | Jyderup Sjaelland, Denmark | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 24, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.