K240998 is an FDA 510(k) clearance for the ABL90 FLEX PLUS System. This device is classified as a Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (Class II - Special Controls, product code CHL).
Submitted by Radiometer Medicals Aps (Brønshøj, DK). The FDA issued a Cleared decision on December 13, 2024, 246 days after receiving the submission on April 11, 2024.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1120.
| 510(k) Number | K240998 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 11, 2024 |
| Decision Date | December 13, 2024 |
| Days to Decision | 246 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CHL - Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1120 |