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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K130037
Device Name BREATHE CPAP SYSTEM
Applicant
Breathe Technologies, Inc.
175 Technology Dr., Suite 100
Irvine,  CA  92618
Applicant Contact CRAIG COOMBS
Correspondent
Breathe Technologies, Inc.
175 Technology Dr., Suite 100
Irvine,  CA  92618
Correspondent Contact CRAIG COOMBS
Regulation Number868.5905
Classification Product Code
BZD  
Date Received01/07/2013
Decision Date 05/17/2013
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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