Cleared Traditional

ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XX

K043218 · Radiometer Medical Aps · Chemistry
May 2005
Decision
169d
Days
Class 2
Risk

About This 510(k) Submission

K043218 is an FDA 510(k) clearance for the ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XX, 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 10, 2005, 169 days after receiving the submission on November 22, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number K043218 FDA.gov
FDA Decision Cleared SESE
Date Received November 22, 2004
Decision Date May 10, 2005
Days to Decision 169 days
Submission Type Traditional
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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