Cleared Abbreviated

VAMOS ANESTHETIC GAS MONITOR

K012139 · Draeger Medical, Inc. · Anesthesiology
Jan 2002
Decision
191d
Days
Class 2
Risk

About This 510(k) Submission

K012139 is an FDA 510(k) clearance for the VAMOS ANESTHETIC GAS MONITOR, a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II — Special Controls, product code CCK), submitted by Draeger Medical, Inc. (Telford, US). The FDA issued a Cleared decision on January 17, 2002, 191 days after receiving the submission on July 10, 2001. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1400.

Submission Details

510(k) Number K012139 FDA.gov
FDA Decision Cleared SESE
Date Received July 10, 2001
Decision Date January 17, 2002
Days to Decision 191 days
Submission Type Abbreviated
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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