Cleared Traditional

ABL90 FLEX PLUS System

K240998 · Radiometer Medicals Aps · Chemistry

Dec 2024

Decision

246d

Days

Class 2

Risk

About This 510(k) Submission

K240998 is an FDA 510(k) clearance for the ABL90 FLEX PLUS System, a Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (Class II — Special Controls, product code CHL), submitted by Radiometer Medicals Aps (Br?nsh?j, 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 review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number	K240998 FDA.gov
FDA Decision	Cleared 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