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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Attachment, Breathing, Positive End Expiratory Pressure
510(k) Number K112546
Device Name O_TWO CPAP SYSTEM
Applicant
O-Two Medical Technologies, Inc.
7575 Kimbel St.
Mississauga,  CA L5S 1C8
Applicant Contact AMMAR AL-DOJAILY
Correspondent
O-Two Medical Technologies, Inc.
7575 Kimbel St.
Mississauga,  CA L5S 1C8
Correspondent Contact AMMAR AL-DOJAILY
Regulation Number868.5965
Classification Product Code
BYE  
Date Received09/01/2011
Decision Date 12/27/2011
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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