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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 K922810
Device Name ODYSSEY
Applicant
O-Two Systems Intl., Inc.
7575 Kimbel St.
Mississauga,  CA L5S 1C8
Applicant Contact KEVIN BOWDEN
Correspondent
O-Two Systems Intl., Inc.
7575 Kimbel St.
Mississauga,  CA L5S 1C8
Correspondent Contact KEVIN BOWDEN
Regulation Number868.5915
Classification Product Code
BTM  
Date Received06/10/1992
Decision Date 01/22/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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