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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K253647
Device Name Evita (V800); Evita (V600)
Applicant
Draegerwerk AG & CO Kgaa
Moislinger Allee 53-55
Luebeck,  DE 23
Applicant Contact Holger Nadler
Correspondent
Draegerwerk AG & CO Kgaa
Moislinger Allee 53-55
Luebeck,  DE 23
Correspondent Contact Holger Nadler
Regulation Number868.5895
Classification Product Code
CBK  
Date Received11/20/2025
Decision Date 05/07/2026
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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