Cleared Traditional

STATCO2METER, MODEL 10-55372

K031814 · Mercury Medical · Anesthesiology
Aug 2003
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K031814 is an FDA 510(k) clearance for the STATCO2METER, MODEL 10-55372, a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II — Special Controls, product code CCK), submitted by Mercury Medical (Clearwater, US). The FDA issued a Cleared decision on August 14, 2003, 63 days after receiving the submission on June 12, 2003. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1400.

Submission Details

510(k) Number K031814 FDA.gov
FDA Decision Cleared SESE
Date Received June 12, 2003
Decision Date August 14, 2003
Days to Decision 63 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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