Cleared Traditional

NARKOMED MRI ANESTHESIA SYSTEM

K972848 · Draeger Medical, Inc. · Anesthesiology
Oct 1997
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K972848 is an FDA 510(k) clearance for the NARKOMED MRI ANESTHESIA SYSTEM, 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 October 30, 1997, 90 days after receiving the submission on August 1, 1997. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5160.

Submission Details

510(k) Number K972848 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 1997
Decision Date October 30, 1997
Days to Decision 90 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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