510(k) K974903
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 13, 1998
- Date Received
- December 31, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
- Device Class
- Class II
- Regulation Number
- 868.1620
- Review Panel
- AN
- Submission Type