Cleared Traditional

Quality Mix Blender, Oxymixer

K221494 · Dehas Medical Systems GmbH · Anesthesiology

Jan 2023

Decision

245d

Days

Class 2

Risk

About This 510(k) Submission

K221494 is an FDA 510(k) clearance for the Quality Mix Blender, Oxymixer, a Mixer, Breathing Gases, Anesthesia Inhalation (Class II — Special Controls, product code BZR), submitted by Dehas Medical Systems GmbH (Luebeck, DE). The FDA issued a Cleared decision on January 23, 2023, 245 days after receiving the submission on May 23, 2022. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5330.

Submission Details

510(k) Number	K221494 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 23, 2022
Decision Date	January 23, 2023
Days to Decision	245 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF