510(k) K161179

Intelli-Ox by Air Liquide Healthcare America Corporation — Product Code ECX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 2017
Date Received
April 26, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cylinder, Compressed Gas, And Valve
Device Class
Class I
Regulation Number
868.2700
Review Panel
AN
Submission Type