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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,  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 Number868.5925
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
Predetermined Change
Control Plan Authorized		 No
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