Cleared Special

ABL800 FLEX with AQURE connectivity

K142898 · Radiometer Medical Aps · Chemistry
Jun 2015
Decision
254d
Days
Class 2
Risk

About This 510(k) Submission

K142898 is an FDA 510(k) clearance for the ABL800 FLEX with AQURE connectivity, a Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (Class II — Special Controls, product code CHL), submitted by Radiometer Medical Aps (Dk-Bronshoj, DK). The FDA issued a Cleared decision on June 17, 2015, 254 days after receiving the submission on October 6, 2014. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number K142898 FDA.gov
FDA Decision Cleared SESE
Date Received October 06, 2014
Decision Date June 17, 2015
Days to Decision 254 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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