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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K170037
Device Name Breathe Technologies Life2000™ Ventilation System
Applicant
Breathe Technologies
175 Technology Dr., Suite 100
Irvine,  CA  92618
Applicant Contact Samir Ahmad
Correspondent
Coombs Medical Device Consulting, Inc.
1193 Sherman St.
Alameda,  CA  94501
Correspondent Contact Craig Coombs
Regulation Number868.5895
Classification Product Code
CBK  
Subsequent Product Codes
BTI   NOU  
Date Received01/04/2017
Decision Date 08/11/2017
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
Recalls CDRH Recalls
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