Cleared Traditional

NARKOMED 6400, MODEL NM6400

K033498 · Draeger Medical, Inc. · Anesthesiology
Apr 2004
Decision
173d
Days
Class 2
Risk

About This 510(k) Submission

K033498 is an FDA 510(k) clearance for the NARKOMED 6400, MODEL NM6400, a Gas-machine, Anesthesia (Class II — Special Controls, product code BSZ), submitted by Draeger Medical, Inc. (Telford, US). The FDA issued a Cleared decision on April 26, 2004, 173 days after receiving the submission on November 5, 2003. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5160.

Submission Details

510(k) Number K033498 FDA.gov
FDA Decision Cleared SESE
Date Received November 05, 2003
Decision Date April 26, 2004
Days to Decision 173 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BSZ — Gas-machine, Anesthesia
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5160

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