Cleared Special

ABL90 FLEX

K120197 · Radiometer Medical Aps · Chemistry
Mar 2012
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K120197 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 (Broenshoej, DK). The FDA issued a Cleared decision on March 19, 2012, 56 days after receiving the submission on January 23, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number K120197 FDA.gov
FDA Decision Cleared SESE
Date Received January 23, 2012
Decision Date March 19, 2012
Days to Decision 56 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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