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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gas-Machine, Anesthesia
510(k) Number K230931
Device Name Atlan
Applicant
Drägerwerk AG Co. Kgaa
Moislinger Allee 53-55
Schleswig-Holstein
Luebeck,  DE 23542
Applicant Contact Marianne Selent
Correspondent
Drägerwerk AG Co. Kgaa
Moislinger Allee 53-55
Schleswig-Holstein
Luebeck,  DE 23542
Correspondent Contact Marianne Selent
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received04/03/2023
Decision Date 07/23/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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