Cleared Traditional

NARKOMED MRI-2 ANESTHESIA SYSTEM, MODEL NM-MRI-2

K022031 · Draeger Medical, Inc. · Anesthesiology
Aug 2002
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K022031 is an FDA 510(k) clearance for the NARKOMED MRI-2 ANESTHESIA SYSTEM, 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 August 29, 2002, 69 days after receiving the submission on June 21, 2002. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5160.

Submission Details

510(k) Number K022031 FDA.gov
FDA Decision Cleared SESE
Date Received June 21, 2002
Decision Date August 29, 2002
Days to Decision 69 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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