510(k) K092313
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 4, 2009
- Date Received
- July 30, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Infusion, Pca
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type