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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, Manual (Resuscitator)
510(k) Number K251631
Device Name The BAG manual resuscitator and accessories
Applicant
Laerdal Medical AS
Tanke Svilandsgate 30
P.O. Box 377
Stavanger,  NO 4002
Applicant Contact Claudia Pajares Ibanez
Correspondent
MED Institute
1330 Win Hentschel Blvd., Suite 100
West Lafayette,  IN  47906
Correspondent Contact Daniel Dillon
Regulation Number868.5915
Classification Product Code
BTM  
Subsequent Product Codes
BYE   CAP  
Date Received05/28/2025
Decision Date 11/24/2025
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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