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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
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