510(k) K241037
K241037 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 January 14, 2025. The device falls under product code CEM (Electrode, Ion Specific, Potassium), a Class II device regulated under 21 CFR 862.1600. Radiometer Medicals Aps has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 14, 2025
- Date Received
- April 16, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Ion Specific, Potassium
- Device Class
- Class II
- Regulation Number
- 862.1600
- Review Panel
- CH
- Submission Type