510(k) K131386
K131386 is an FDA 510(k) premarket notification submitted by Air Liquide Healthcare America for the device "EZ-OX PLUS GENERATION II". The FDA issued a decision of Substantially Equivalent on March 14, 2014. 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 has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 14, 2014
- Date Received
- May 14, 2013
- 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