Cleared Special

ABL90 FLEX

K123748 · Radiometer Medical Aps · Chemistry
May 2013
Decision
152d
Days
Class 2
Risk

About This 510(k) Submission

K123748 is an FDA 510(k) clearance for the ABL90 FLEX, a Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (Class II — Special Controls, product code CHL), submitted by Radiometer Medical Aps (Bronshoj, DK). The FDA issued a Cleared decision on May 7, 2013, 152 days after receiving the submission on December 6, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number K123748 FDA.gov
FDA Decision Cleared SESE
Date Received December 06, 2012
Decision Date May 07, 2013
Days to Decision 152 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CHL — Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1120

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