510(k) K050107
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 11, 2005
- Date Received
- January 18, 2005
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Infusion
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type