K251200
- 510(k) number
- K251200
- Device name
- Vital Signs
- Applicant
- Oxehealth Limited GB
- Product code
- QME — Software For Optical Camera-Based Measurement Of Pul
- Decision date
- 2026-02-02
- Date received
- 2025-04-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K251200.pdf
Official FDA record: K251200
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.