510(k) K063096
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 27, 2007
- Date Received
- October 10, 2006
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Gas, Oxygen, Gaseous-Phase
- Device Class
- Class II
- Regulation Number
- 868.1720
- Review Panel
- AN
- Submission Type