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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, Non-Life-Supporting
510(k) Number K240778
Device Name Vivo 1, Vivo 2
Applicant
Breas Medical AB
Foretagsvagen 1
Molnlycke,  SE 45333
Applicant Contact Ivan Liljegren
Correspondent
OConnell Regulatory Consultants, Inc.
44 Oak Street
Stoneham,  MA  02180
Correspondent Contact Maureen OConnell
Regulation Number868.5895
Classification Product Code
MNS  
Subsequent Product Code
NOU  
Date Received03/21/2024
Decision Date 12/13/2024
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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