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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 K071702
Device Name BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 40
Applicant
BREAS MEDICAL AB
FORETAGSVAGEN 1
MOLNLYCKE,  SE 435 33
Applicant Contact IBB JESSEN
Correspondent
BREAS MEDICAL AB
FORETAGSVAGEN 1
MOLNLYCKE,  SE 435 33
Correspondent Contact IBB JESSEN
Regulation Number868.5895
Classification Product Code
MNT  
Date Received06/21/2007
Decision Date 02/15/2008
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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