510(k) K820063
K820063 is an FDA 510(k) premarket notification submitted by Hedeco for the device "KEOFEED 500 ENTERIC FEEDING PUMP". The FDA issued a decision of Substantially Equivalent on February 10, 1982. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Hedeco has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 10, 1982
- Date Received
- January 11, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Infusion
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type