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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device coronary artery disease risk indicator from acoustic heart signals
Regulation Description Coronary artery disease risk indicator using acoustic heart signals.
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.
Product CodeQMW
Regulation Number 870.1420
Device Class 2


Premarket Reviews
ManufacturerDecision
ACARIX A/S
  GRANTED 1

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