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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cylinder, Compressed Gas, And Valve
510(k) Number K161179
Device Name Intelli-Ox
Applicant
Air Liquide Healthcare America Corporation
12800 W. Little York Rd.
Houston,  TX  77041 -2280
Applicant Contact Steve Miller
Correspondent
Air Liquide Healthcare America Corporation
12800 W. Little York Rd.
Houston,  TX  77041 -2280
Correspondent Contact Steve Miller
Regulation Number868.2700
Classification Product Code
ECX  
Date Received04/26/2016
Decision Date 04/13/2017
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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