510(k) K994188
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 19, 2000
- Date Received
- December 13, 1999
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
- Device Class
- Class II
- Regulation Number
- 868.1500
- Review Panel
- AN
- Submission Type