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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 K252746
Device Name Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)
Applicant
Drägerwerk AG Co. Kgaa
Moislinger Allee 53 - 55
Lübeck,  DE 23542
Applicant Contact Laura Weaver
Correspondent
Drägerwerk AG Co. Kgaa
Moislinger Allee 53 - 55
Lübeck,  DE 23542
Correspondent Contact Laura Weaver
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received08/29/2025
Decision Date 05/21/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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