510(k) K010566
K010566 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "COLLEAGUE VOLUMETRIC INFUSION PUMP". The FDA issued a decision of Substantially Equivalent on May 15, 2001. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 15, 2001
- Date Received
- Feb 26, 2001
- 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
- 510(k)