K261389
- 510(k) number
- K261389
- Device name
- PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)
- Applicant
- Salter Labs TX · US
- Product code
- CCL — Analyzer, Gas, Oxygen, Gaseous-Phase
- Decision date
- 2026-07-30
- Date received
- 2026-04-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K261389.pdf
Official FDA record: K261389
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.