510(k) K192563
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 17, 2020
- Date Received
- September 17, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- Device Class
- Class II
- Regulation Number
- 868.1400
- Review Panel
- AN
- Submission Type