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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mechanical Ventilator
510(k) Number K131562
Device Name BREATHE NIOV VENTILATION SYSTEM
Applicant
BREATHE TECHNOLOGIES
1193 SHERMAN ST
ALAMEDA,  CA  94501
Applicant Contact CRAIG COOMBS
Correspondent
BREATHE TECHNOLOGIES
1193 SHERMAN ST
ALAMEDA,  CA  94501
Correspondent Contact CRAIG COOMBS
Regulation Number868.5895
Classification Product Code
ONZ  
Date Received05/30/2013
Decision Date 03/06/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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