Cleared Traditional

MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM

K030624 · Draeger Medical, Inc. · Anesthesiology
Mar 2004
Decision
384d
Days
Class 2
Risk

About This 510(k) Submission

K030624 is an FDA 510(k) clearance for the MODIFICATION TO FABIUS GS 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 March 17, 2004, 384 days after receiving the submission on February 27, 2003. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5160.

Submission Details

510(k) Number K030624 FDA.gov
FDA Decision Cleared SESE
Date Received February 27, 2003
Decision Date March 17, 2004
Days to Decision 384 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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