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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 K193586
Device Name Vivo 45 LS
Applicant
Breas Medical AB
Foretagsvagen 1
Molnlycke,  SE SE-453 33
Applicant Contact Ari Sobel
Correspondent
O'Connell Regulatory Consultants, Inc.
44 Oak St.
Stoneham,  MA  02180
Correspondent Contact Maureen O'Connell
Regulation Number868.5895
Classification Product Code
NOU  
Subsequent Product Codes
BTT   CBK   CCK   DQA  
Date Received12/23/2019
Decision Date 01/27/2021
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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