510(k) DEN250057
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- May 22, 2026
- Date Received
- November 17, 2025
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Software Device System For Estimation Of Cardiac Pressures
- Device Class
- Class II
- Regulation Number
- 870.1150
- Review Panel
- CV
- Submission Type
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.