Cleared Special

NARKOMED MRI , NM-MRI

K001488 · Draeger Medical, Inc. · Anesthesiology
Jun 2000
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K001488 is an FDA 510(k) clearance for the NARKOMED MRI , NM-MRI, 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 June 9, 2000, 28 days after receiving the submission on May 12, 2000. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5160.

Submission Details

510(k) Number K001488 FDA.gov
FDA Decision Cleared SESE
Date Received May 12, 2000
Decision Date June 09, 2000
Days to Decision 28 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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