510(k) K011587
K011587 is an FDA 510(k) premarket notification submitted by Entracon Corp. for the device "SENTINEL ENTERAL FEEDING PUMP, LH2001 ENTERAL FEEDING PUMP". The FDA issued a decision of Substantially Equivalent on June 1, 2001. 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 1, 2001
- Date Received
- May 23, 2001
- 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