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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
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