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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Valve, Non-Rebreathing
510(k) Number K241366
Device Name QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)
Applicant
Dehas Medical Systems GmbH
Wesloer Straße 107-109
Luebeck,  DE 23568
Applicant Contact Jens Mittendorf
Correspondent
Draeger Medical Systems, Inc.
3135 Quarry Rd.
Telford,  PA  18969
Correspondent Contact Jens Mittendorf
Regulation Number868.5870
Classification Product Code
CBP  
Date Received05/14/2024
Decision Date 10/29/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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