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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Continuous, Ventilator, Home Use
510(k) Number K160481
Device Name Vivo 60
Applicant
BREAS MEDICAL AB
FORETAGSVAGEN 1
MOLNLYCKE VASTRA GOTALANDS LAN,  SE 435 33
Applicant Contact Albert Cefalo
Correspondent
O'CONNELL REGULATORY CONSULTANTS, INC.
5 TIMBER LANE
North Reading,  MA  01864
Correspondent Contact Maureen O'Connell
Regulation Number868.5895
Classification Product Code
NOU  
Subsequent Product Codes
CBK   CCK   DQA  
Date Received02/22/2016
Decision Date 11/09/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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