Cleared Special

NARKOMED MRI-2, MODEL NM-MRI-2

K003579 · Draeger Medical, Inc. · Anesthesiology
Jan 2001
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K003579 is an FDA 510(k) clearance for the NARKOMED MRI-2, MODEL NM-MRI-2, 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 January 22, 2001, 63 days after receiving the submission on November 20, 2000. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5160.

Submission Details

510(k) Number K003579 FDA.gov
FDA Decision Cleared SESE
Date Received November 20, 2000
Decision Date January 22, 2001
Days to Decision 63 days
Submission Type Special
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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