510(k) K003047
K003047 is an FDA 510(k) premarket notification submitted by Ross Product Div. Abbott Laboratories for the device "AMBULATORY ENTERAL NUTRITION PUMP". The FDA issued a decision of Substantially Equivalent on June 12, 2001. 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
- June 12, 2001
- Date Received
- September 29, 2000
- 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