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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 K123144
Device Name VIVO 50
Applicant
Ge Healthcare, Breas Medical AB
Foretagsvagen 1
Molnlycke,  SE 435 33
Applicant Contact SHLOMI DELER
Correspondent
Ge Healthcare, Breas Medical AB
Foretagsvagen 1
Molnlycke,  SE 435 33
Correspondent Contact SHLOMI DELER
Regulation Number868.5895
Classification Product Code
NOU  
Subsequent Product Codes
CBK   CCK   DQA  
Date Received10/05/2012
Decision Date 06/18/2013
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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