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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, ONTARIO,  CA L5S 1C8
Applicant Contact AMMAR AL-DOJAILY
Correspondent
O-TWO MEDICAL TECHNOLOGIES, INC.
7575 KIMBEL ST.
MISSISSAUGA, ONTARIO,  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
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