K250078
- 510(k) number
- K250078
- Device name
- Informed Vital Core Application (IVC App) (v2.0.0.2.0.0)
- Applicant
- Mindset Medical, Inc. AZ · US
- Product code
- QME — Software For Optical Camera-Based Measurement Of Pul
- Decision date
- 2025-05-30
- Date received
- 2025-01-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250078.pdf
Official FDA record: K250078
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.