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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 K060546
Device Name BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 30
Applicant
Breas Medical AB
Foretagsvagen 1
Molnlycke, Vastra Gotaland,  SE SE-435 33
Applicant Contact KARL-JOHAN HOLM
Correspondent
Breas Medical AB
Foretagsvagen 1
Molnlycke, Vastra Gotaland,  SE SE-435 33
Correspondent Contact KARL-JOHAN HOLM
Regulation Number868.5895
Classification Product Code
MNS  
Date Received03/01/2006
Decision Date 05/26/2006
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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