K240998
- 510(k) number
- K240998
- Device name
- ABL90 FLEX PLUS System
- Applicant
- Radiometer Medicals Aps DK
- Product code
- CHL — Electrode Measurement, Blood-Gases (Pco2, Po2) And B
- Decision date
- 2024-12-13
- Date received
- 2024-04-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
510(k) Summary (official FDA PDF): K240998.pdf
Official FDA record: K240998
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.