510(k) K011868
K011868 is an FDA 510(k) premarket notification submitted by Debio Tech SA for the device "ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETS". The FDA issued a decision of Substantially Equivalent on September 4, 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
- September 4, 2001
- Date Received
- June 14, 2001
- 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