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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 K082982
Device Name BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES
Applicant
Breathe Technologies, Inc.
1193 Sherman St.
Alameda,  CA  94501
Applicant Contact CRAIG COOMBS
Correspondent
Breathe Technologies, Inc.
1193 Sherman St.
Alameda,  CA  94501
Correspondent Contact CRAIG COOMBS
Regulation Number868.5895
Classification Product Code
ONZ  
Date Received10/06/2008
Decision Date 07/20/2009
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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