510(k) K063354
K063354 is an FDA 510(k) premarket notification submitted by Linde Gas Therapeutics for the device "LINDE INTEGRATED VALVE (LIV)". The FDA issued a decision of Substantially Equivalent on April 17, 2007. The device falls under product code ECX (Cylinder, Compressed Gas, And Valve), a Class I device regulated under 21 CFR 868.2700. Linde Gas Therapeutics has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 17, 2007
- Date Received
- November 6, 2006
- 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