K254129
- 510(k) number
- K254129
- Device name
- Spectrum-2
- Applicant
- Neko Health AB SE
- Product code
- MUD — Oximeter, Tissue Saturation
- Decision date
- 2026-05-22
- Date received
- 2025-12-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K254129.pdf
Official FDA record: K254129
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.