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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 K103345
Device Name BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S)
Applicant
Breathe Technologies, Inc.
4000 Executive Pkwy.,
Suite 190
San Ramon,  CA  94583
Applicant Contact JOSEPH CIPILLONE
Correspondent
Breathe Technologies, Inc.
4000 Executive Pkwy.,
Suite 190
San Ramon,  CA  94583
Correspondent Contact JOSEPH CIPILLONE
Regulation Number868.5895
Classification Product Code
ONZ  
Date Received11/15/2010
Decision Date 02/11/2011
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
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