Cleared Traditional

DIVAN ANESTHESIA VENTILATOR

K980208 · Draeger Medical, Inc. · Anesthesiology
Aug 1998
Decision
196d
Days
Class 2
Risk

About This 510(k) Submission

K980208 is an FDA 510(k) clearance for the DIVAN ANESTHESIA VENTILATOR, a Ventilator, Continuous, Facility Use (Class II — Special Controls, product code CBK), submitted by Draeger Medical, Inc. (Telford, US). The FDA issued a Cleared decision on August 4, 1998, 196 days after receiving the submission on January 20, 1998. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K980208 FDA.gov
FDA Decision Cleared SESE
Date Received January 20, 1998
Decision Date August 04, 1998
Days to Decision 196 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CBK — Ventilator, Continuous, Facility Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5895

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