510(k) K003616
K003616 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "COLLEAGUE (3CX, 3, CX) VOLUMETRIC INFUSION PUMP". The FDA issued a decision of Substantially Equivalent on Dec 12, 2000. 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
- Dec 12, 2000
- Date Received
- Nov 22, 2000
- Clearance Type
- Special
- 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)