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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Valve, Non-Rebreathing
510(k) Number K940927
Device Name RESCUE BREATHER
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 Number868.5870
Classification Product Code
CBP  
Date Received02/28/1994
Decision Date 10/14/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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