510(k) K031407
K031407 is an FDA 510(k) premarket notification submitted by Ross Product Div. Abbott Laboratories for the device "ROSS EMBRACE ENTERAL PUMP". The FDA issued a decision of Substantially Equivalent on May 20, 2003. The device falls under product code LZH (Pump, Infusion, Enteral), a Class II device regulated under 21 CFR 880.5725. Ross Product Div. Abbott Laboratories has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 20, 2003
- Date Received
- May 5, 2003
- Clearance Type
- Special
- 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