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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
Breas Medical AB
Foretagsvagen 1
Molnlyeke,  SE SE-453 33
Applicant Contact Ari Sobel
O'Connell Regulatory Consultants, Inc.
44 Oak Street
Stoneham,  MA  02180
Correspondent Contact Maureen O'Connell
Regulation Number868.5895
Classification Product Code
Subsequent Product Codes
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
Recalls CDRH Recalls