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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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