Cleared Traditional

NARKOMED 6000 MODEL NUMBER NM6000

K980553 · Draeger Medical, Inc. · Anesthesiology
Aug 1998
Decision
173d
Days
Class 2
Risk

About This 510(k) Submission

K980553 is an FDA 510(k) clearance for the NARKOMED 6000 MODEL NUMBER NM6000, 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 4, 1998, 173 days after receiving the submission on February 12, 1998. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5160.

Submission Details

510(k) Number K980553 FDA.gov
FDA Decision Cleared SESE
Date Received February 12, 1998
Decision Date August 04, 1998
Days to Decision 173 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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