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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 K100528
Device Name BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2S
Applicant
BREATHE TECHNOLOGIES, INC.
4000 EXECUTIVE PARKWAY,
SUITE 190
SAN RAMON,  CA  94583
Applicant Contact SUZON LOMMEL
Correspondent
BREATHE TECHNOLOGIES, INC.
4000 EXECUTIVE PARKWAY,
SUITE 190
SAN RAMON,  CA  94583
Correspondent Contact SUZON LOMMEL
Regulation Number868.5895
Classification Product Code
ONZ  
Date Received02/24/2010
Decision Date 04/23/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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