510(k) K252475
K252475 is an FDA 510(k) premarket notification submitted by Radiometer Medicals Aps for the device "ABL90 FLEX PLUS System". The FDA issued a decision of Substantially Equivalent on May 1, 2026. The device falls under product code JGS (Electrode, Ion Specific, Sodium), a Class II device regulated under 21 CFR 862.1665. Radiometer Medicals Aps has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 1, 2026
- Date Received
- August 7, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Ion Specific, Sodium
- Device Class
- Class II
- Regulation Number
- 862.1665
- Review Panel
- CH
- Submission Type