510(k) K911838
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 19, 1991
- Date Received
- April 25, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Coulometric Method, Carbon-Dioxide
- Device Class
- Class II
- Regulation Number
- 862.1160
- Review Panel
- CH
- Submission Type