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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
Recalls CDRH Recalls
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