510(k) K973896
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 21, 1998
- Date Received
- October 14, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gas-Machine, Anesthesia
- Device Class
- Class II
- Regulation Number
- 868.5160
- Review Panel
- AN
- Submission Type