K252207
- 510(k) number
- K252207
- Device name
- ABL90 FLEX PLUS System, safeCLINITUBES
- Applicant
- Radiometer Medicals Aps DK
- Product code
- CHL — Electrode Measurement, Blood-Gases (Pco2, Po2) And B
- Decision date
- 2026-04-10
- Date received
- 2025-07-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K252207.pdf
Official FDA record: K252207
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.