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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 K991195
Device Name CAREVENT BLS, CAREVENT BLS+, CAREVENT ALS, CAREVENT ALS+, AND CAREVENT ATV
Applicant
O-Two Systems Intl., Inc.
7575 Kimbel St., Unit 5
Mississauga
Ontario L5s 1c8,  CA
Applicant Contact KEVIN BOWDEN
Correspondent
O-Two Systems Intl., Inc.
7575 Kimbel St., Unit 5
Mississauga
Ontario L5s 1c8,  CA
Correspondent Contact KEVIN BOWDEN
Regulation Number868.5925
Classification Product Code
BTL  
Date Received04/08/1999
Decision Date 04/22/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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