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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, Manual (Resuscitator)
510(k) Number K021328
Device Name SMART BAG MO
Applicant
O-Two Systems International, Inc.
7575 Kimbel St.
Mississauga,  CA L5S 1C8
Applicant Contact KEVIN BOWDEN
Correspondent
O-Two Systems International, Inc.
7575 Kimbel St.
Mississauga,  CA L5S 1C8
Correspondent Contact KEVIN BOWDEN
Regulation Number868.5915
Classification Product Code
BTM  
Date Received04/26/2002
Decision Date 06/26/2003
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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