Cleared Traditional

DRAGER-VAPOR 19.3

K981773 · Draeger Medical, Inc. · Anesthesiology
Jul 1998
Decision
47d
Days
Class 2
Risk

About This 510(k) Submission

K981773 is an FDA 510(k) clearance for the DRAGER-VAPOR 19.3, 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 July 6, 1998, 47 days after receiving the submission on May 20, 1998. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5880.

Submission Details

510(k) Number K981773 FDA.gov
FDA Decision Cleared SESE
Date Received May 20, 1998
Decision Date July 06, 1998
Days to Decision 47 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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