510(k) K023805
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 11, 2003
- Date Received
- November 14, 2002
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Valve, Non-Rebreathing
- Device Class
- Class II
- Regulation Number
- 868.5870
- Review Panel
- AN
- Submission Type