510(k) K002739
K002739 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K". The FDA issued a decision of Substantially Equivalent on September 11, 2000. The device falls under product code MEA (Pump, Infusion, Pca), a Class II device regulated under 21 CFR 880.5725. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 11, 2000
- Date Received
- September 1, 2000
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Infusion, Pca
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type