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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Emergency, Powered (Resuscitator)
510(k) Number K242769
Device Name VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)
Applicant
Draegerwerk AG & CO Kgaa
Moislinger Allee 53-55
Luebeck,  DE 23542
Applicant Contact Jan Upmeier
Correspondent
Draegerwerk AG & CO Kgaa
Moislinger Allee 53-55
Luebeck,  DE 23542
Correspondent Contact Jan Upmeier
Regulation Number868.5925
Classification Product Code
BTL  
Subsequent Product Code
BZE  
Date Received09/13/2024
Decision Date 04/04/2025
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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