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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,  CA L5S 1C8
Applicant Contact David Zhang
Correspondent
O-Two Medical Technologies, Inc.
7575 Kimbel St.
Mississauga,  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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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