Cleared Special

ABL90 FLEX

K130144 · Radiometer Medical Aps · Chemistry
Jul 2013
Decision
190d
Days
Class 2
Risk

About This 510(k) Submission

K130144 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 July 31, 2013, 190 days after receiving the submission on January 22, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number K130144 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 2013
Decision Date July 31, 2013
Days to Decision 190 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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