510(k) K003579
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 22, 2001
- Date Received
- November 20, 2000
- Clearance Type
- Special
- 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