510(k) K112402
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 14, 2011
- Date Received
- August 22, 2011
- 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