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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 K141595
Device Name O-TWO E700,O-TWO E600,O-TWO E500
Applicant
O-TWO MEDICAL TECHNOLOGIES, INC.
7575 KIMBEL ST.
MISSISSAUGA, ONTARIO,  CA L5S 1C8
Applicant Contact David Zhang
Correspondent
O-TWO MEDICAL TECHNOLOGIES, INC.
7575 KIMBEL ST.
MISSISSAUGA, ONTARIO,  CA L5S 1C8
Correspondent Contact David Zhang
Regulation Number868.5925
Classification Product Code
BTL  
Date Received06/13/2014
Decision Date 03/16/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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