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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 K983643
Device Name GENESIS BLS
Applicant
O-TWO SYSTEMS INTL., INC.
7575 KIMBEL ST.
MISSISSAUGA, ONTARIO,  CA L5S 1C8
Applicant Contact KEVIN BOWDEN
Correspondent
O-TWO SYSTEMS INTL., INC.
7575 KIMBEL ST.
MISSISSAUGA, ONTARIO,  CA L5S 1C8
Correspondent Contact KEVIN BOWDEN
Regulation Number868.5925
Classification Product Code
BTL  
Date Received10/16/1998
Decision Date 10/29/1998
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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