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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 K173205
Device Name Equinox Advantage
Applicant
O-Two Medical Technologies, Inc.
45a Armthorpe Rd.
Brampton,  CA l6t 5m4
Applicant Contact David Zhang
Correspondent
O-Two Medical Technologies, Inc.
45a Armthorpe Rd.
Brampton,  CA l6t 5m4
Correspondent Contact David Zhang
Regulation Number868.5330
Classification Product Code
BZR  
Date Received10/02/2017
Decision Date 08/29/2018
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
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