K254169
- 510(k) number
- K254169
- Device name
- SmartSpectra Vital Signs Monitor 1.0
- Applicant
- Presage Security, Inc. d/b/a Presage Technologies, Inc. VA · US
- Product code
- QME — Software For Optical Camera-Based Measurement Of Pul
- Decision date
- 2026-06-18
- Date received
- 2025-12-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K254169.pdf
Official FDA record: K254169
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.