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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mixer, Breathing Gases, Anesthesia Inhalation
510(k) Number K113687
Device Name EQUINOX RELIEVE
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 Number868.5330
Classification Product Code
BZR  
Date Received12/15/2011
Decision Date 04/30/2012
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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