Software Device System For Estimation Of Cardiac Pressures

Product Code

SIF

Device Class

FDA class 2

Regulation Number

870.1150

Medical Specialty

Cardiovascular

Review Panel

CV

Submission Type

1

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.

This FDA classification is associated with 1 510(k) clearance via K numbers.