Cleared Traditional

D-VAPOR

K042276 · Draeger Medical, Inc. · Anesthesiology
Sep 2004
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K042276 is an FDA 510(k) clearance for the D-VAPOR, a Vaporizer, Anesthesia, Non-heated (Class II — Special Controls, product code CAD), submitted by Draeger Medical, Inc. (Telford, US). The FDA issued a Cleared decision on September 23, 2004, 31 days after receiving the submission on August 23, 2004. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5880.

Submission Details

510(k) Number K042276 FDA.gov
FDA Decision Cleared SESE
Date Received August 23, 2004
Decision Date September 23, 2004
Days to Decision 31 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CAD — Vaporizer, Anesthesia, Non-heated
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5880

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