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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device software device system for estimation of cardiac pressures
Definition This prescription-only device uses machine learning-based algorithms to analyze one or more non-invasive physiologic signals or parameters to estimate a cardiac pressure (e.g. pulmonary capillary wedge pressure, left ventricular end diastolic pressure, or pulmonary artery pressure.) This device is intended for adjunctive use with patient information and is not intended to independently direct therapy. The device may contain hardware sensors. This device is not intended to estimate systemic, vascular blood pressure.
Product CodeSIF
Regulation Number 870.1150
Device Class 2


Premarket Reviews
ManufacturerDecision
CARDIOSENSE, INC.
  GRANTED 1

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