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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Emergency, Powered (Resuscitator)
510(k) Number K051889
Device Name CAREVENT CA AND DRA
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 Number868.5925
Classification Product Code
BTL  
Date Received07/12/2005
Decision Date 08/30/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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