Cleared Special

ABL90

K111897 · Radiometer Medical Aps · Chemistry
Jul 2011
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K111897 is an FDA 510(k) clearance for the ABL90, a Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (Class II — Special Controls, product code CHL), submitted by Radiometer Medical Aps (Copenhagen, DK). The FDA issued a Cleared decision on July 19, 2011, 14 days after receiving the submission on July 5, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number K111897 FDA.gov
FDA Decision Cleared SESE
Date Received July 05, 2011
Decision Date July 19, 2011
Days to Decision 14 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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