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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name mixer, breathing gases, anesthesia inhalation
510(k) Number K221494
Device Name Quality Mix Blender, Oxymixer
DEHAS Medical Systems GmbH
Wesloer Strabe 112
Luebeck,  DE 23568
Applicant Contact Jens Mittendorf
Draeger Medical Systems GmBH
3135 Quarry Road
Telford,  PA  18969
Correspondent Contact Tom Hirte
Regulation Number868.5330
Classification Product Code
Date Received05/23/2022
Decision Date 01/23/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No