510(k) K161179
K161179 is an FDA 510(k) premarket notification submitted by Air Liquide Healthcare America Corporation for the device "Intelli-Ox". The FDA issued a decision of Substantially Equivalent on April 13, 2017. The device falls under product code ECX (Cylinder, Compressed Gas, And Valve), a Class I device regulated under 21 CFR 868.2700. Air Liquide Healthcare America Corporation has at least 1 other 510(k) clearance on record.
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