510(k) K771516
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 16, 1977
- Date Received
- August 8, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Gas, Nitrogen, Gaseous-Phase
- Device Class
- Class II
- Regulation Number
- 868.1690
- Review Panel
- AN
- Submission Type