510(k) K902113
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 26, 1990
- Date Received
- May 11, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
- Device Class
- Class II
- Regulation Number
- 868.1430
- Review Panel
- AN
- Submission Type