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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, Minimal Ventilatory Support, Facility Use
510(k) Number K090113
Device Name BREAS VIVO 40 SYSTEM
Applicant
Breas Medical AB
Foretagsvagen 1
Molnlycke,  SE 435 33
Applicant Contact BIRGITTA BOLANDER
Correspondent
Breas Medical AB
Foretagsvagen 1
Molnlycke,  SE 435 33
Correspondent Contact BIRGITTA BOLANDER
Regulation Number868.5895
Classification Product Code
MNT  
Date Received01/21/2009
Decision Date 05/14/2009
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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