Cleared Traditional

NEO-STAT CO2
K083056 · Mercury Medical · Anesthesiology

Feb 2009
Decision
132d
Days
Class 2
Risk

About This 510(k) Submission

K083056 is an FDA 510(k) clearance for the NEO-STAT CO2 <KG, a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II — Special Controls, product code CCK), submitted by Mercury Medical (Bonita Springs, US). The FDA issued a Cleared decision on February 23, 2009, 132 days after receiving the submission on October 14, 2008. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1400.

Submission Details

510(k) Number K083056 FDA.gov
FDA Decision Cleared SESE
Date Received October 14, 2008
Decision Date February 23, 2009
Days to Decision 132 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CCK — Analyzer, Gas, Carbon-dioxide, Gaseous-phase
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1400

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