510(k) K060316
K060316 is an FDA 510(k) premarket notification submitted by Fresenius Kabi Deutschland GmbH for the device "COMPAT GO ENTERAL FEEDING PUMP AND ADMINISTRATION SETS". The FDA issued a decision of Substantially Equivalent on June 23, 2006. The device falls under product code LZH (Pump, Infusion, Enteral), a Class II device regulated under 21 CFR 880.5725.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 23, 2006
- Date Received
- February 8, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Pump, Infusion, Enteral
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type