510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QMWClass II

Coronary Artery Disease Risk Indicator From Acoustic Heart Signals

21 CFR 870.1420 / Cardiovascular
FDA source (opens on fda.gov)

QMW is the FDA product code for Coronary Artery Disease Risk Indicator From Acoustic Heart Signals, a class II device type, regulated under 21 CFR 870.1420. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QMW
Device name
Coronary Artery Disease Risk Indicator From Acoustic Heart Signals
FDA 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.
Regulation
21 CFR 870.1420
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code QMW

By decision year
1 clearance under product code QMW with a decision year between 2020 and 2020, 2020 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QMW by decision year
YearClearances
20201

Applicants with the most clearances

Product code QMW
Applicants holding the most 510(k) clearances under product code QMW
ApplicantClearances
Acarix AS1

Companies listing this code with FDA

Companies whose registered establishments list this code