510(k) K143263
K143263 is an FDA 510(k) premarket notification submitted by Covidien for the device "Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets". The FDA issued a decision of Substantially Equivalent on May 29, 2015. The device falls under product code LZH (Pump, Infusion, Enteral), a Class II device regulated under 21 CFR 880.5725. Covidien has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 29, 2015
- Date Received
- November 13, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Infusion, Enteral
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type