SIF

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Software Device System For Estimation Of Cardiac Pressures

Device class

Class II (moderate risk)

Regulation

21 CFR 870.1150

Medical specialty

Cardiovascular

FDA 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.

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