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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 K222207
Device Name Babylog VN800, Babylog VN600
Applicant
Draegerwerk AG & CO KGaA
53/55 Moislinger Allee
Luebeck,  DE 23542
Applicant Contact Nataliia Semenova
Correspondent
Draegerwerk AG & CO KGaA
53/55 Moislinger Allee
Luebeck,  DE 23542
Correspondent Contact Nataliia Semenova
Regulation Number868.5895
Classification Product Code
CBK  
Date Received07/25/2022
Decision Date 05/16/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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